Blank Casebook Report for Study VCU FLT 8029 … Blank Casebook 9... · Blank Casebook Report for...
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Blank Casebook Report for Study VCU_FLT_8029, Casebook BOOK AMENDMENT 5
Report run by GLENNA GABRIELLI at 22-SEP-2010 12:11:45
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Table of Contents
PRE-STUDY.............................................................................................................................4ELIGIBILITY - A...........................................................................................................................................4Ancillary Data Section for ELIGIBILITY - A...............................................................................................7ENROLLMENT.............................................................................................................................................8BASELINE MEDICAL HISTORY.............................................................................................................11Ancillary Data Section for BASELINE MEDICAL HISTORY..................................................................14BASELINE SYMPTOMS............................................................................................................................15BREAST CANCER HIST............................................................................................................................17CHEMOTHERAPY ADMIN.......................................................................................................................20PRE PROLIFERATION INDEX.................................................................................................................22BLOOD CHEMISTRY................................................................................................................................24Ancillary Data Section for BLOOD CHEMISTRY.....................................................................................27HEMATOLOGY..........................................................................................................................................28Ancillary Data Section for HEMATOLOGY...............................................................................................31OTHER LABS..............................................................................................................................................32PRE PATHOLOGY......................................................................................................................................35PRIOR TREATMENT SUMMARY............................................................................................................38TUMOR_SLIDE_TRANSMITTAL............................................................................................................41
BASELINEIMGNFLT1........................................................................................................45COURSE INITIATION................................................................................................................................45BASE FDG TECH........................................................................................................................................48BASE FLT TECH.........................................................................................................................................52COURSE ASSESSMENT............................................................................................................................56OTHER IMAGING......................................................................................................................................59
EARLYTHERIMGFLT2......................................................................................................60COURSE INITIATION................................................................................................................................60MID-TREAT FDG TECH ASSESS.............................................................................................................63MID-TREAT FLT TECH ASSESS..............................................................................................................67COURSE ASSESSMENT............................................................................................................................71OTHER IMAGING......................................................................................................................................74
POSTCHEMOIMGFLT3.....................................................................................................75COURSE INITIATION................................................................................................................................75POST TREAT FDG TECH..........................................................................................................................78POST-TREAT FLT TECH ASSESS............................................................................................................82COURSE ASSESSMENT............................................................................................................................86OTHER IMAGING......................................................................................................................................89
SURGICAL RESECT...........................................................................................................90SURG PATHOL...........................................................................................................................................90POST PROLIFERATION INDEX...............................................................................................................93TUMOR_SLIDE_TRANSMITTAL............................................................................................................95RESIDUAL CAN BURDEN........................................................................................................................99
OFF-TREATMENT............................................................................................................102OFF TREAT...............................................................................................................................................102
OFF-STUDY.........................................................................................................................103OFF STUDY...............................................................................................................................................103
CONMED.............................................................................................................................106CONCOMITANT MEDS...........................................................................................................................106
AE..........................................................................................................................................108ADVERSE EVENTS V4............................................................................................................................108
Visit Name CRF Blank
Study
Visit Date
Patient
Section blank?
INCLUSION CRITERIAY / N / NAEligibility Criteria
Waiver #
Sequence
Effective DateChecklist #
ELIGIBILITY CHECKLIST
Criteria Response
3
ELIGIBILTA (v1, 11-MAR-2010)Doc#
Visit# CRF Page
FormStatus
Subevent#of
Note: Dates will appear as 'DD-MON-YYYY'
201001211
7F
PRE-STUDY
VCU_FLT_8029
AST(SGOT)/ALT(SGPT) <= 2.5 times the institutional upper limit of normal7E
total bilirubin within normal institutional limits7D
platelets >= 100,000/ul7C
absolute neutrophil count >= 1,500/ul7B
1
leukocytes >= 3,000/ul7A
Patient has normal organ and marrow function as defined below at first visit and pre-chemotherapy7
Patient is age 18 years or older6
Patient is able to lie still for 1.5 hours for PET scanning
6
10
4
5
Patient has residual tumor planned to be removed surgically following completion of neoadjuvant therapy
a1.1
4
Able to understand and willing to sign a written informed consent document and a HIPAA authorization in accordance with institutional guidelines
Patient has no obvious contraindications for primary chemotherapy
10
Patient's ECOG performance status is <=2
3
32
Patient has a tumor size >2cm, measured on imaging or estimated by physical exam
9
2
If female, patient has been postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, conf. by B-HCG blood test and willing to use adequate contraception for duration of study.
Patient has path. conf. breast cancer, is determined to be a candidate for primary systemic (neoadjuvant) ther. and for surgical resection of residual primary tumor following completion of neo. ther.
8
creatinine within normal institutional limits OR estimated creatinine clearance >= 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal5
1
Visit Name CRF Blank
Study
Visit Date
Patient
Section blank?
EXCLUSION CRITERIA
N/ANOYESIn the opinion of the investigator, is the patient eligible?
Y / N / NAEligibility CriteriaSequence
ELIGIBILITY CHECKLIST
Criteria Response
3
ELIGIBILTA (v1, 11-MAR-2010)Doc#
Visit# CRF Page
FormStatus
Subevent#of
Note: Dates will appear as 'DD-MON-YYYY'
Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to F-18 fluorothymidine10
11
1
PRE-STUDY
VCU_FLT_8029
5
Patient has a condition requiring anesthesia for PET scanning and/or unable to lie still for 1.5 hours
10
4
7
a1.2
Patient is medically unstable
Patient is currently on hormone therapy
3
9
Pat. has uncontrolled inter. illness including, but not limited to, act. Infect., sympt. cong. heart failure, unstable A.P., C.A., or psych illness/social sit. that would limit compliance with study2
Patient has had previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which s/he has been disease free for less than 5 years.
9
8
8Patient has received previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy
Patient is pregnant or nursing7
Patient is under age 186
Visit Name CRF Blank
Study
Visit Date
Patient
Section blank?
NoteDate
COMMENTS
3
ELIGIBILTA (v1, 11-MAR-2010)Doc#
Visit# CRF Page
FormStatus
Subevent#of
Note: Dates will appear as 'DD-MON-YYYY'
10 a1.3
PRE-STUDY
VCU_FLT_8029
a1.3.OS.1
Overflow/Investigator Comments/Discrepancy Detail/Audit History for CRF ELIGIBILITY - A
1
2
3
4
5
6
7
8
9
10
11
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Treatment Assignment Code at Enrollment
Native Hawaiian or other Pacific Islander
Patient Subgroup
American Indian or Alaska Native
Registering Group
Disease Stage at Entry
Hispanic or Latino
Black or African American
Registering Institution
Unknown
Race Not Reported
Not Hispanic or Latino
Race Unknown
Not ReportedAsian
Ethnicity
CONSENT
DEMOGRAPHY
Local Patient ID
Country Code
Disease Term
Date of Informed Consent Version
White
GEOGRAPHY AND GROUP
Postal Code
Primary Site
Patient Gender
Patient Initials
Method of Payment
Date Informed Consent Signed
Female
Date of Registration
ECOG Performance Status
MaleUnknown
Date of Birth
5-Medicaid and Medicare, 6-Military or Veterans Sponsored NOS, 6a - Military Sponsored (incl. CHAMPUS and TRICARE,
ENROLLMENT
Race: select all that apply
6b-Veterans Sponsored, 7-Self Pay (No insurance), 8-No means of payment (no insurance), 98-Other, 99-Unknown
Method of payment: 1-Private Insurance, 2-Medicare, 3-Medicare and Private Insurance, 4- Medicaid,
HISTORY
Form
3
ENROLLMENT (v1, 18-NOV-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
a2.110
PRE-STUDY
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
NotesDate
COMMENTS
Form
3
ENROLLMENT (v1, 18-NOV-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
10
PRE-STUDY
VCU_FLT_8029
a2.2
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
ENROLLMENT (v1, 18-NOV-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
PRE-STUDY
a2.3
VCU_FLT_8029
10
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Obstetric History
Medical History If AbnormalBody System
AbortionsMiscarriagesABORTUSPARA
PregnanciesGRAVIDA
Live Births\
Stil Births
BASELINE MEDICAL HISTORY
Form
3
BASELINE M (v1, 30-MAR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
GASTROINTESTINAL
10
CARDIOVASCULAR
RESPIRATORY
OTHER
IMMUNE
NECK
PSYCHOLOGIC
URINARY
ENDOCRINE/METABOLIC
HEMATOPOIETIC/LYMPH2
DERMATOLOGIC
a3.1
MUSCULOSKELETAL
NEUROLOGIC
ABDOMEN
1
PELVIS
H/E/E/N/T
BREASTS
GENITALIA
PRE-STUDY
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
NotesDate
COMMENTS
Form
3
BASELINE M (v1, 30-MAR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
a3.210
PRE-STUDY
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
BASELINE M (v1, 30-MAR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
PRE-STUDY
a3.310
VCU_FLT_8029
a3.3.OS.1
Overflow/Investigator Comments/Discrepancy Detail/Audit History for CRF BASELINE MEDICAL HISTORY
1
2
Visit Name CRF Blank
Study
Visit Date
Patient
Section blank?
GradeSymptom DescriptionCTCAE TermResolvedOnset
Related To DiseaseDateDate ofBASELINE SYMPTOMS
UnknownNoYes
2
BASELINE S (v1, 02-MAR-2010)Doc#
Visit# CRF Page
FormStatus
Subevent#of
Note: Dates will appear as 'DD-MON-YYYY'
PRE-STUDY
VCU_FLT_8029
10 a4.1
Visit Name CRF Blank
Study
Visit Date
Patient
Section blank?
NoteDate
COMMENTS
2
BASELINE S (v1, 02-MAR-2010)Doc#
Visit# CRF Page
FormStatus
Subevent#of
Note: Dates will appear as 'DD-MON-YYYY'
a4.2
VCU_FLT_8029
10
PRE-STUDY
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
BILATERAL
FAS
M1T4a
PN3
Tis
AI + FAS + OS
Specify:
T0
T2 PN1C
FAS + OS
M Stage
T4b
T1b
BREAST CANCER HISTORY
Other hormonal therapies
T1
Primary breast cancer diagnosis date
NONE
T Stage
M0
T4c
OTHER (SPECIFY)
Tis (LCIS)
T1a
PN3B
Laterality (Right/Left Side)
Tis (Paget's) PN2
T4d
PNX
LEFT
PN0T4
MX
PN2B
T1c
RIGHT
AI + OS
PN1MIT3PN0(I+)
TXPN3C
AI
PN0(I-) PN2ATis (DCIS)
PN3A
T1mic
-------------------------------------Primary Cancer Staging------------------------------------------
N Stage
PN1BPN1APN1PN0(MOL-)PN0(MOL+)
Menopausal Status Pre-Menopausal Post-Menopausal
Age at diagnosis
Unknown
LMP Date
Form
3
BREAST CAN (v1, 31-MAR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
PRE-STUDY
a5.1
VCU_FLT_8029
10
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
COMMENTS
Date Notes
Form
3
BREAST CAN (v1, 31-MAR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
a5.2
PRE-STUDY
10
VCU_FLT_8029
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
BREAST CAN (v1, 31-MAR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# ofa5.310
PRE-STUDY
VCU_FLT_8029
Visit Name CRF Blank
Study
Visit Date
Patient
Section blank?
CHEMOTHERAPY ADMINISTRATION
Start StopDate Date Medication Dose Dose Unit Route
2
CHEMOTHERA (v1, 20-AUG-2009)Doc#
Visit# CRF Page
FormStatus
Subevent#of
Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
10
PRE-STUDY
a6.1
Visit Name CRF Blank
Study
Visit Date
Patient
Section blank?
NoteDate
COMMENTS
2
CHEMOTHERA (v1, 20-AUG-2009)Doc#
Visit# CRF Page
FormStatus
Subevent#of
Note: Dates will appear as 'DD-MON-YYYY'
PRE-STUDY
VCU_FLT_8029
10 a6.2
Visit Name CRF Blank
Study
Visit Date
Patient
Section blank?
HPF 3
HPF 1
HPF 6
HPF10Staining Grade
Biomarker Name % Positive CellsYes
Total # of Cells
No
Mitotic Count #
Sample Collection Date Pathology #
Lesion ID#Analyzed
Analyzed
No
HPF 9
HPF 4
0 1 2
HPF 5
PROLIFERATION INDEX - PRE-TREATMENT
HPF 7HPF 8
HPF 2
Yes
Mitotic Index
2
PREPROLIF (v1, 03-SEP-2009)Doc#
Visit# CRF Page
FormStatus
Subevent#of
Note: Dates will appear as 'DD-MON-YYYY'
PRE-STUDY
VCU_FLT_8029
10 a7.1
Visit Name CRF Blank
Study
Visit Date
Patient
Section blank?
COMMENTSDate Note
2
PREPROLIF (v1, 03-SEP-2009)Doc#
Visit# CRF Page
FormStatus
Subevent#of
Note: Dates will appear as 'DD-MON-YYYY'
PRE-STUDY
VCU_FLT_8029
10 a7.2
Visit Name
CRF BlankStudy
Lab Date
Patient
Section blank?Lab
---Manual Overrides--
Ranges
BLOOD CHEMISTRY
Value inNormal
GradeRanges IndicatorNormal Sigificant
Clinically
YesRange
No
-----Centrally stored-----
UnitsPreferredUnitsLab Test Lab Value Units
Form
3
BLOOD CHEM (v1, 01-APR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
BUN_SER
POTASSIUM_SER
PRE-STUDY
VCU_FLT_8029
ALT_SGPT_SER
ALK_PHOS_SER
LDH_SER
a8.110
4
SODIUM_SER
GLUCOSE_NONFAST_SER
BILIRUB_TTL_SER
AST_SGOT_SER
3
2
CREATININE_SER
AMYLASE_SER
1
ALBUMIN_SER
Visit Name
CRF BlankStudy
Lab Date
Patient
Section blank?
NotesDate
COMMENTS
Form
3
BLOOD CHEM (v1, 01-APR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
a8.210
PRE-STUDY
Visit Name
CRF BlankStudy
Lab Date
Patient
Note
COMMENTS
Date
Form
3
BLOOD CHEM (v1, 01-APR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# ofa8.310
PRE-STUDY
VCU_FLT_8029
a8.3.OS.1
Overflow/Investigator Comments/Discrepancy Detail/Audit History for CRF BLOOD CHEMISTRY
1
2
3
4
Visit Name
CRF BlankStudy
Lab Date
Patient
Section blank?Lab
------Overrides-----
HEMATOLOGY
UnitsUnits PreferredUnitsLab ValueLab Test
--Centrally Stored--Range
Ranges
Value inNormal
GradeIndicatorRangesSigificantYes
NormalNo
Clinically
Form
3
HEMATOLOGY (v1, 01-APR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
HGB_BLD
PLATELET_BLD
PRE-STUDY
VCU_FLT_8029
RDW_RBC
MCV_RBC
BASO_PCT_BLD
LYMPH_PC_BLD
a9.110
WBC_NUM_BLD
MCHC_RBC
RBC_NUM_BLD
EOSINOPHIL_PC_BLD
PMV_BLD
1
NEUT_PC_BLD
HCT_BLD
MCH_RBC
MONO_PC_BLD
Visit Name
CRF BlankStudy
Lab Date
Patient
Section blank?
NotesDate
COMMENTS
Form
3
HEMATOLOGY (v1, 01-APR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
PRE-STUDY
a9.210
VCU_FLT_8029
Visit Name
CRF BlankStudy
Lab Date
Patient
Note
COMMENTS
Date
Form
3
HEMATOLOGY (v1, 01-APR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# ofa9.310
PRE-STUDY
VCU_FLT_8029
Visit Name
CRF BlankStudy
Lab Date
Patient
Section blank?
OTHER LABS
Lab Test Value *
* Expected values are NEG or POS.
Form
3
OTHER LABS (v1, 13-APR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
10 a10.1
PRE-STUDY
Visit Name
CRF BlankStudy
Lab Date
Patient
Section blank?
NotesDate
COMMENTS
Form
3
OTHER LABS (v1, 13-APR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
a10.210
PRE-STUDY
VCU_FLT_8029
Visit Name
CRF BlankStudy
Lab Date
Patient
Note
COMMENTS
Date
Form
3
OTHER LABS (v1, 13-APR-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
a10.310
PRE-STUDY
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Surgical Biopsy Core Needle Biopsy
Status
ER
Type of Specimen
Breast Cancer Location
PRE-TREATMENT PATHOLOGYRIGHTLEFTBILATERAL
NT: Non-Target)POS / NEG
Receptor Status
21Primary Nottingham Grade 3
Lesion ID
OTHER (SPECIFY)Other, specify
MUCINOUSINVASIVE DUCTAL INVASIVE LOBULAR MIXED INVASIVE & LOBULARDCIS
Primary cancer type
UNKNOWNPOSITIVE UNKNOWNPOSITIVENEGATIVE
NEGATIVENEGATIVE POSITIVE UNKNOWN
Diameter 1(cm) Diameter 2(cm)
HER2
(TA: Target
PR
Form
3
PRE PATHOL (v1, 15-OCT-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
PRE-STUDY
VCU_FLT_8029
a11.110
Visit Name
CRF BlankStudy
Visit Date
Patient
COMMENTS
Date Notes
Form
3
PRE PATHOL (v1, 15-OCT-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
PRE-STUDY
a11.2
VCU_FLT_8029
10
Visit Name
CRF BlankStudy
Visit Date
Patient
COMMENTS
NoteDate
Form
3
PRE PATHOL (v1, 15-OCT-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
a11.310
PRE-STUDY
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Therapy Type Date of Last Dose# of Prior Chemo
PRIOR TREATMENT SUMMARY
RegimensYes / NoAny therapy
Form
3
PRIOR TREA (v1, 04-NOV-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
CHEMOTHERAPY SINGLE AGENT SYSTEMIC
PRE-STUDY
EXTENSIVE RADIATION
VCU_FLT_8029
CHEMOTHERAPY NON-CYTOTOXIC
a12.1
DRUG AND/OR IMMUNOTHERAPY
10
PRIOR THERAPY (NOS)
SURGERY
GENE TRANSFER
VACCINE
HORMONAL THERAPY
BONE MARROW TRANSPLANT
ONCOLYTIC VIROTHERAPY
CHEMOTHERAPY (NOS)
RADIATION (NOS)
ANTISENSE
CHEMOTHERAPY MULTIPLE AGENTS SYSTEMIC
LIMITED RADIATION
ANTI-RETROVIRAL THERAPY
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
NotesDate
COMMENTS
Form
3
PRIOR TREA (v1, 04-NOV-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
a12.2
VCU_FLT_8029
10
PRE-STUDY
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
PRIOR TREA (v1, 04-NOV-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of10
PRE-STUDY
VCU_FLT_8029
a12.3
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Slides
ALL study participants' personal identifying information (participant name, medical record number, SS#, etc.) on all
Timepoint in study: (select one) POST (VISIT 5)PRE (VISIT 1)
Were slides paraffin blocks able to be sent? (select one)
Date Form Completed
Number of slides
Specimen lost
Initials of Person from Site Completing This Form
Not allowed by institution
Date slides blocks reports Sent to Path Lab
Tumor Slides Transmittal Form
Provide reason unable to send slides paraffin blocks
Type of tissue submitted: (check all that apply)
Date of surgical procedure
Yes
Other, specify
number of blocks
Other, specify
No
Richmond, VA 23298-0470
RE: ACRIN 6688 Pathology
P.O. Box 980470
of the material is de-identified
1101 East Marshall Street, Room 4-065
Each slide block report is labeled with the study number, site number, patient case number and pre or post timepoint.
Virginia Commonwealth University Health System
(complete then intial, sign and date form and send to address listed below along with reports)
Part A. Completed by Site RA
The pathology specimens, pathology report, imaging report and this form should be shipped to the central pathology
Megan Quinnlaboratory to:
Paraffin block(s)
Before Sending the Slides Blocks and reports, please check to confirm:
Form
4
TUMOR_SLID (v2, 02-SEP-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
PRE-STUDY
VCU_FLT_8029
a13.110
Visit Name
CRF BlankStudy
Visit Date
Patient
Have specimen(s) been received in an acceptable condition?
Date Form Completed
Number of blocks received
Initials of Person from Site Completing This Form
Number of slides received
Yes
Date Slides Blocks Received
No
Part B. Completed by VCU Path Lab
Form
4
TUMOR_SLID (v2, 02-SEP-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
a13.2
PRE-STUDY
10
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
NotesDate
COMMENTS
Form
4
TUMOR_SLID (v2, 02-SEP-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
a13.3
PRE-STUDY
10
VCU_FLT_8029
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
4
TUMOR_SLID (v2, 02-SEP-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
PRE-STUDY
VCU_FLT_8029
a13.410
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Note: This form is for the FLT scan only.
Start Date of Course
Treating Institution
COURSE INITIATION
Course#
Has patient agreed to use contraception during protocol?
N/A, patient is not of reproductive potential
No
Not Applicable
Yes
Unknown
Form
3
COURSE INI (v3, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
BASELINEIMGNFLT1
VCU_FLT_8029
b1.130
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
COMMENTS
Date Notes
Form
3
COURSE INI (v3, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
BASELINEIMGNFLT1
b1.230
VCU_FLT_8029
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
COURSE INI (v3, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
b1.330
BASELINEIMGNFLT1
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Unit
Unit
Unit
Injection
If no,
Was imaging agent administered?
PET Tracer
Administration dateNoYes
Blood glucose before injection of FDG
Any radiotracer infiltration at injection site noted?
Date of imagingBSA
Method
Location of Injection Site
Right wrist Left wrist
Purchased
Oral
Was imaging exam completed?
Other, specify
Right Hand Left Hand
SEVERE ( greater than 20% OF DOSE)
Synthesized
IV
Net activity administered
If imaging not completed provide reason
Height
Activity in full syringe before injection
Left footRight foot
MINOR ( less than or equal to 20% OF DOSE)
Other Location of Injection Site
Source of agent
Route of administration
NONE
Central Venous Access Device
Left antecubitalRight antecubital
Weight
Supplier
Lot #
Other, specifyUnknown
Patient voided immediately pre-imaging
Duration of fasting pre-PET imaging (Hours)
Patient voided immediately post-imaging
No
Unknown
Yes
YesUnknown
Was Foley catheter placed?
NoYes
Fasting
Time blood sample was obtained for glucose measurement
No
No Yes
Other, specify
Scheduling problem
Participant death
Equipment failure
Participant refusal
Adverse event
Participant withdrew
Imaging agent not administered
Claustrophobia
Injection site complications
unknown
Medical reason Progressive Disease
mg/dl
FDG Technical Assessment
Time of assay of full syringe before injection
Time of injectionResidual activity in syringe after injection
Time of assay of residual activity after injection
YesNo
Form
4
BASE FDG T (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
BASELINEIMGNFLT1
VCU_FLT_8029
b2.130
Visit Name
CRF BlankStudy
Visit Date
Patient
(minutes)
time
NOT DONE
(ml)
YesNo
YesNo
used
time
PET Emission Scan
images(mm)used?
of reconstructed
Check to confirm scanner is the same scanner used for all previous protocol scans for this participant
contrast
(ml)
Mode
used? Value origin
Position
Scanner specs
Amountattenuation
Injection
transmissionSlice thicknesscontrast scan
Date of last PET scanner SUV validation
Model Name/or number
Manufacturer
if yes provide scanner ID#
Daily scanner QC run on date of study
if no, specify reasonHas the scanner used for this study been qualified by ACRIN?
Oral
Acquisition Type of Scan
NOT DONE
Oral
Scan stop
Type of
Scan start
Was IV
CT Image Acquisition
Time per bed Thickness (mm)# of Bed Pixel Size (mm)
(If first scan, check to confirm scanner will be used for future protocol scans for this participant)
correction contrast
mAstype KVP
Time of
Position
Amount
Form
4
BASE FDG T (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
BASELINEIMGNFLT1
VCU_FLT_8029
b2.230
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
NotesDate
COMMENTS
Form
4
BASE FDG T (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
b2.330
BASELINEIMGNFLT1
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
4
BASE FDG T (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
BASELINEIMGNFLT1
VCU_FLT_8029
b2.430
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
YesNo
Unit
Unit
Unit
Injection
If no,
Scheduling problem
Source of agent
Yes Administration date
Equipment failure
Other, specify
unknown
Other Location of Injection Site
Oral Central Venous Access Device
Participant refusal Participant withdrew
Left wrist
Left foot
Lot #
No
Date of imaging
Adverse event
No Unknown
Right wrist
Right footLeft antecubital
Method
Yes
Claustrophobia
No
Yes
Right antecubital
PET Tracer
Was imaging agent administered?
Was imaging exam completed?
Was Foley catheter placed?
Other, specify
Supplier
No
Injection site complications
Duration of fasting pre-PET imaging (Hours)
Net activity administered
Activity in full syringe before injection
Purchased
NONE
Imaging agent not administered
Yes
NoPatient voided immediately post-imaging
Synthesized
Location of Injection Site
Any radiotracer infiltration at injection site noted?
Progressive Disease
Yes
Unknown
Right Hand
Route of administration
SEVERE ( greater than 20% OF DOSE)
Medical reason
Fasting
Unknown
Other, specify
Left Hand
IV
MINOR ( less than or equal to 20% OF DOSE)
If imaging not completed provide reason
Participant death
Patient voided immediately pre-imaging
Height BSAWeight
FLT Technical Assessment
Time of assay of full syringe before injectionTime of injectionResidual activity in syringe after injection
Time of assay of residual activity after injection
Form
4
BASE FLT T (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
BASELINEIMGNFLT1
VCU_FLT_8029
b3.130
Visit Name
CRF BlankStudy
Visit Date
Patient
Time ofmAsKVPused
Amount Amount
Check to confirm scanner is the same scanner used for all previous protocol scans for this participant
Value origin
(If first scan, check to confirm scanner will be used for future protocol scans for this participant)
InjectioncontrastWas IV
Position
CT Image Acquisition
if yes provide scanner ID#
scan
Time per bed
used?
Scan start Pixel Size (mm)
contrast
Type of
Scanner specs
Manufacturer
used?
Model Name/or number
Position# of Bed Thickness (mm)
if no, specify reason
correction
Daily scanner QC run on date of study
YesNoHas the scanner used for this study been qualified by ACRIN?
Mode time
transmission
(ml)
Date of last PET scanner SUV validation
type (minutes)
Oral
No
Acquisition
Yes
contrastimages(mm)
NOT DONE
Scan stop
attenuation
PET Emission Scan
timeType of Scan
Oralof reconstructed
NOT DONE
Slice thickness
(ml)
Form
4
BASE FLT T (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
BASELINEIMGNFLT1
VCU_FLT_8029
b3.230
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
NotesDate
COMMENTS
Form
4
BASE FLT T (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
b3.3
VCU_FLT_8029
30
BASELINEIMGNFLT1
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
4
BASE FLT T (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
b3.4
BASELINEIMGNFLT1
30
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Note: This form is for the FLT scan only.
COURSE ASSESSMENT
No
Complete Response
Date of Response
Date of Progression
Partial Response
Any Adverse Events in this Course ?
Not Assessed
Yes
Response Note
Not Evaluable
No
Not Applicable per Protocol
Course Disposition
Completed
Yes, Unplanned
Discontinued
Start Date of Course
Yes, Planned
Unknown
Too Early to assess, per protocol
Dose change from TAC entered on Course Initiation CRF ?
Minimal/Marginal Response
Stable DiseaseProgressive Disease
Disease Unchanged
Response Assessment
Form
3
COURSE ASS (v2, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
30 b4.1
BASELINEIMGNFLT1
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?COMMENTS
Date Notes
Form
3
COURSE ASS (v2, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
BASELINEIMGNFLT1
b4.230
VCU_FLT_8029
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
COURSE ASS (v2, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of30
BASELINEIMGNFLT1
VCU_FLT_8029
b4.3
Visit Name
CRF BlankStudy
Visit Date
Patient
mm x
YESNOCT scan
mm
mmmm
Lesion ID
mm x
Location Measurement 1 Measurement 2
mm
Date of Imaging
mm xmm
mm xmm x
mm x
mm
mm
Lesion ID
mm x
Date of Imaging
mm xmm xmm x mm
Location Measurement 1 Measurement 2
mm
mm
YESNOMRI
mm
mm
mm x
LocationLesion IDDate of Imaging Measurement 2Measurement 1
mm x
mm x
mmmm x
YESNOUltrasound
mmmm x
mm
mm x
Was a mammogram performed No Yes
Date of Imaging Lesion ID
mm
mmmm
mm x
mm xmm x
mmmm x
mm
Measurement 2Measurement 1Location
Form
1
OTHER IMAG (v1, 15-MAR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
Other Imaging
BASELINEIMGNFLT1
b5
VCU_FLT_8029
30
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Note: This form is for the FLT scan only.
Start Date of Course
Treating Institution
COURSE INITIATION
Course#
Has patient agreed to use contraception during protocol?
N/A, patient is not of reproductive potential
No
Not Applicable
Yes
Unknown
Form
3
COURSE INI (v3, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
EARLYTHERIMGFLT2
VCU_FLT_8029
c1.150
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
COMMENTS
Date Notes
Form
3
COURSE INI (v3, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
EARLYTHERIMGFLT2
c1.250
VCU_FLT_8029
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
COURSE INI (v3, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
c1.350
EARLYTHERIMGFLT2
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Unit
Unit
Unit
Injection
If no,
Was imaging agent administered?
PET Tracer
Administration dateNoYes
Blood glucose before injection of FDG
Any radiotracer infiltration at injection site noted?
Date of imagingBSA
Method
Location of Injection Site
Right wrist Left wrist
Purchased
Oral
Was imaging exam completed?
Other, specify
Right Hand Left Hand
SEVERE ( greater than 20% OF DOSE)
Synthesized
IV
Net activity administered
If imaging not completed provide reason
Height
Activity in full syringe before injection
Left footRight foot
MINOR ( less than or equal to 20% OF DOSE)
Other Location of Injection Site
Source of agent
Route of administration
NONE
Central Venous Access Device
Left antecubitalRight antecubital
Weight
Supplier
Lot #
Other, specifyUnknown
Patient voided immediately pre-imaging
Duration of fasting pre-PET imaging (Hours)
Patient voided immediately post-imaging
No
Unknown
Yes
YesUnknown
Was Foley catheter placed?
NoYes
Fasting
Time blood sample was obtained for glucose measurement
No
No Yes
Other, specify
Scheduling problem
Participant death
Equipment failure
Participant refusal
Adverse event
Participant withdrew
Imaging agent not administered
Claustrophobia
Injection site complications
unknown
Medical reason Progressive Disease
mg/dl
FDG Technical Assessment
Time of assay of full syringe before injection
Time of injectionResidual activity in syringe after injection
Time of assay of residual activity after injection
YesNo
Form
4
MIDFDGASS (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
EARLYTHERIMGFLT2
VCU_FLT_8029
c2.150
Visit Name
CRF BlankStudy
Visit Date
Patient
(minutes)
time
NOT DONE
(ml)
YesNo
YesNo
used
time
PET Emission Scan
images(mm)used?
of reconstructed
Check to confirm scanner is the same scanner used for all previous protocol scans for this participant
contrast
(ml)
Mode
used? Value origin
Position
Scanner specs
Amountattenuation
Injection
transmissionSlice thicknesscontrast scan
Date of last PET scanner SUV validation
Model Name/or number
Manufacturer
if yes provide scanner ID#
Daily scanner QC run on date of study
if no, specify reasonHas the scanner used for this study been qualified by ACRIN?
Oral
Acquisition Type of Scan
NOT DONE
Oral
Scan stop
Type of
Scan start
Was IV
CT Image Acquisition
Time per bed Thickness (mm)# of Bed Pixel Size (mm)
(If first scan, check to confirm scanner will be used for future protocol scans for this participant)
correction contrast
mAstype KVP
Time of
Position
Amount
Form
4
MIDFDGASS (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
EARLYTHERIMGFLT2
VCU_FLT_8029
c2.250
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
COMMENTS
Date Notes
Form
4
MIDFDGASS (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
c2.350
EARLYTHERIMGFLT2
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
4
MIDFDGASS (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
EARLYTHERIMGFLT2
VCU_FLT_8029
c2.450
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
YesNo
Unit
Unit
Unit
Injection
If no,
Scheduling problem
Source of agent
Yes Administration date
Equipment failure
Other, specify
unknown
Other Location of Injection Site
Oral Central Venous Access Device
Participant refusal Participant withdrew
Left wrist
Left foot
Lot #
No
Date of imaging
Adverse event
No Unknown
Right wrist
Right footLeft antecubital
Method
Yes
Claustrophobia
No
Yes
Right antecubital
PET Tracer
Was imaging agent administered?
Was imaging exam completed?
Was Foley catheter placed?
Other, specify
Supplier
No
Injection site complications
Duration of fasting pre-PET imaging (Hours)
Net activity administered
Activity in full syringe before injection
Purchased
NONE
Imaging agent not administered
Yes
NoPatient voided immediately post-imaging
Synthesized
Location of Injection Site
Any radiotracer infiltration at injection site noted?
Progressive Disease
Yes
Unknown
Right Hand
Route of administration
SEVERE ( greater than 20% OF DOSE)
Medical reason
Fasting
Unknown
Other, specify
Left Hand
IV
MINOR ( less than or equal to 20% OF DOSE)
If imaging not completed provide reason
Participant death
Patient voided immediately pre-imaging
Height BSAWeight
FLT Technical Assessment
Time of assay of full syringe before injectionTime of injectionResidual activity in syringe after injection
Time of assay of residual activity after injection
Form
4
MIDFLTASS (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
EARLYTHERIMGFLT2
VCU_FLT_8029
c3.150
Visit Name
CRF BlankStudy
Visit Date
Patient
Time ofmAsKVPused
Amount Amount
Check to confirm scanner is the same scanner used for all previous protocol scans for this participant
Value origin
(If first scan, check to confirm scanner will be used for future protocol scans for this participant)
InjectioncontrastWas IV
Position
CT Image Acquisition
if yes provide scanner ID#
scan
Time per bed
used?
Scan start Pixel Size (mm)
contrast
Type of
Scanner specs
Manufacturer
used?
Model Name/or number
Position# of Bed Thickness (mm)
if no, specify reason
correction
Daily scanner QC run on date of study
YesNoHas the scanner used for this study been qualified by ACRIN?
Mode time
transmission
(ml)
Date of last PET scanner SUV validation
type (minutes)
Oral
No
Acquisition
Yes
contrastimages(mm)
NOT DONE
Scan stop
attenuation
PET Emission Scan
timeType of Scan
Oralof reconstructed
NOT DONE
Slice thickness
(ml)
Form
4
MIDFLTASS (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
EARLYTHERIMGFLT2
VCU_FLT_8029
c3.250
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
COMMENTS
Date Notes
Form
4
MIDFLTASS (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
c3.3
VCU_FLT_8029
50
EARLYTHERIMGFLT2
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
4
MIDFLTASS (v3, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
c3.4
EARLYTHERIMGFLT2
50
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Note: This form is for the FLT scan only.
COURSE ASSESSMENT
No
Complete Response
Date of Response
Date of Progression
Partial Response
Any Adverse Events in this Course ?
Not Assessed
Yes
Response Note
Not Evaluable
No
Not Applicable per Protocol
Course Disposition
Completed
Yes, Unplanned
Discontinued
Start Date of Course
Yes, Planned
Unknown
Too Early to assess, per protocol
Dose change from TAC entered on Course Initiation CRF ?
Minimal/Marginal Response
Stable DiseaseProgressive Disease
Disease Unchanged
Response Assessment
Form
3
COURSE ASS (v2, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
50 c4.1
EARLYTHERIMGFLT2
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?COMMENTS
Date Notes
Form
3
COURSE ASS (v2, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
EARLYTHERIMGFLT2
c4.250
VCU_FLT_8029
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
COURSE ASS (v2, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of50
EARLYTHERIMGFLT2
VCU_FLT_8029
c4.3
Visit Name
CRF BlankStudy
Visit Date
Patient
mm x
YESNOCT scan
mm
mmmm
Lesion ID
mm x
Location Measurement 1 Measurement 2
mm
Date of Imaging
mm xmm
mm xmm x
mm x
mm
mm
Lesion ID
mm x
Date of Imaging
mm xmm xmm x mm
Location Measurement 1 Measurement 2
mm
mm
YESNOMRI
mm
mm
mm x
LocationLesion IDDate of Imaging Measurement 2Measurement 1
mm x
mm x
mmmm x
YESNOUltrasound
mmmm x
mm
mm x
Was a mammogram performed No Yes
Date of Imaging Lesion ID
mm
mmmm
mm x
mm xmm x
mmmm x
mm
Measurement 2Measurement 1Location
Form
1
OTHER IMAG (v1, 15-MAR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
Other Imaging
EARLYTHERIMGFLT2
c5
VCU_FLT_8029
50
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Note: This form is for the FLT scan only.
Start Date of Course
Treating Institution
COURSE INITIATION
Course#
Has patient agreed to use contraception during protocol?
N/A, patient is not of reproductive potential
No
Not Applicable
Yes
Unknown
Form
3
COURSE INI (v3, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
POSTCHEMOIMGFLT3
VCU_FLT_8029
d1.165
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
COMMENTS
Date Notes
Form
3
COURSE INI (v3, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
POSTCHEMOIMGFLT3
d1.265
VCU_FLT_8029
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
COURSE INI (v3, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
d1.365
POSTCHEMOIMGFLT3
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Unit
Unit
Unit
Injection
If no,
Was imaging agent administered?
PET Tracer
Administration dateNoYes
Blood glucose before injection of FDG
Any radiotracer infiltration at injection site noted?
Date of imagingBSA
Method
Location of Injection Site
Right wrist Left wrist
Purchased
Oral
Was imaging exam completed?
Other, specify
Right Hand Left Hand
SEVERE ( greater than 20% OF DOSE)
Synthesized
IV
Net activity administered
If imaging not completed provide reason
Height
Activity in full syringe before injection
Left footRight foot
MINOR ( less than or equal to 20% OF DOSE)
Other Location of Injection Site
Source of agent
Route of administration
NONE
Central Venous Access Device
Left antecubitalRight antecubital
Weight
Supplier
Lot #
Other, specifyUnknown
Patient voided immediately pre-imaging
Duration of fasting pre-PET imaging (Hours)
Patient voided immediately post-imaging
No
Unknown
Yes
YesUnknown
Was Foley catheter placed?
NoYes
Fasting
Time blood sample was obtained for glucose measurement
No
No Yes
Other, specify
Scheduling problem
Participant death
Equipment failure
Participant refusal
Adverse event
Participant withdrew
Imaging agent not administered
Claustrophobia
Injection site complications
unknown
Medical reason Progressive Disease
mg/dl
FDG Technical Assessment
Time of assay of full syringe before injection
Time of injectionResidual activity in syringe after injection
Time of assay of residual activity after injection
YesNo
Form
4
POSTFDGTA (v2, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
POSTCHEMOIMGFLT3
VCU_FLT_8029
d2.165
Visit Name
CRF BlankStudy
Visit Date
Patient
(minutes)
time
NOT DONE
(ml)
YesNo
YesNo
used
time
PET Emission Scan
images(mm)used?
of reconstructed
Check to confirm scanner is the same scanner used for all previous protocol scans for this participant
contrast
(ml)
Mode
used? Value origin
Position
Scanner specs
Amountattenuation
Injection
transmissionSlice thicknesscontrast scan
Date of last PET scanner SUV validation
Model Name/or number
Manufacturer
if yes provide scanner ID#
Daily scanner QC run on date of study
if no, specify reasonHas the scanner used for this study been qualified by ACRIN?
Oral
Acquisition Type of Scan
NOT DONE
Oral
Scan stop
Type of
Scan start
Was IV
CT Image Acquisition
Time per bed Thickness (mm)# of Bed Pixel Size (mm)
(If first scan, check to confirm scanner will be used for future protocol scans for this participant)
correction contrast
mAstype KVP
Time of
Position
Amount
Form
4
POSTFDGTA (v2, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
POSTCHEMOIMGFLT3
VCU_FLT_8029
d2.265
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
COMMENTS
Date Notes
Form
4
POSTFDGTA (v2, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
d2.365
POSTCHEMOIMGFLT3
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
4
POSTFDGTA (v2, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
POSTCHEMOIMGFLT3
VCU_FLT_8029
d2.465
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
YesNo
Unit
Unit
Unit
Injection
If no,
Scheduling problem
Source of agent
Yes Administration date
Equipment failure
Other, specify
unknown
Other Location of Injection Site
Oral Central Venous Access Device
Participant refusal Participant withdrew
Left wrist
Left foot
Lot #
No
Date of imaging
Adverse event
No Unknown
Right wrist
Right footLeft antecubital
Method
Yes
Claustrophobia
No
Yes
Right antecubital
PET Tracer
Was imaging agent administered?
Was imaging exam completed?
Was Foley catheter placed?
Other, specify
Supplier
No
Injection site complications
Duration of fasting pre-PET imaging (Hours)
Net activity administered
Activity in full syringe before injection
Purchased
NONE
Imaging agent not administered
Yes
NoPatient voided immediately post-imaging
Synthesized
Location of Injection Site
Any radiotracer infiltration at injection site noted?
Progressive Disease
Yes
Unknown
Right Hand
Route of administration
SEVERE ( greater than 20% OF DOSE)
Medical reason
Fasting
Unknown
Other, specify
Left Hand
IV
MINOR ( less than or equal to 20% OF DOSE)
If imaging not completed provide reason
Participant death
Patient voided immediately pre-imaging
Height BSAWeight
FLT Technical Assessment
Time of assay of full syringe before injectionTime of injectionResidual activity in syringe after injection
Time of assay of residual activity after injection
Form
4
POSTFLTASS (v2, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
POSTCHEMOIMGFLT3
VCU_FLT_8029
d3.165
Visit Name
CRF BlankStudy
Visit Date
Patient
Time ofmAsKVPused
Amount Amount
Check to confirm scanner is the same scanner used for all previous protocol scans for this participant
Value origin
(If first scan, check to confirm scanner will be used for future protocol scans for this participant)
InjectioncontrastWas IV
Position
CT Image Acquisition
if yes provide scanner ID#
scan
Time per bed
used?
Scan start Pixel Size (mm)
contrast
Type of
Scanner specs
Manufacturer
used?
Model Name/or number
Position# of Bed Thickness (mm)
if no, specify reason
correction
Daily scanner QC run on date of study
YesNoHas the scanner used for this study been qualified by ACRIN?
Mode time
transmission
(ml)
Date of last PET scanner SUV validation
type (minutes)
Oral
No
Acquisition
Yes
contrastimages(mm)
NOT DONE
Scan stop
attenuation
PET Emission Scan
timeType of Scan
Oralof reconstructed
NOT DONE
Slice thickness
(ml)
Form
4
POSTFLTASS (v2, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
POSTCHEMOIMGFLT3
VCU_FLT_8029
d3.265
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
COMMENTS
Date Notes
Form
4
POSTFLTASS (v2, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
d3.3
VCU_FLT_8029
65
POSTCHEMOIMGFLT3
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
4
POSTFLTASS (v2, 05-MAY-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
d3.4
POSTCHEMOIMGFLT3
65
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Note: This form is for the FLT scan only.
COURSE ASSESSMENT
No
Complete Response
Date of Response
Date of Progression
Partial Response
Any Adverse Events in this Course ?
Not Assessed
Yes
Response Note
Not Evaluable
No
Not Applicable per Protocol
Course Disposition
Completed
Yes, Unplanned
Discontinued
Start Date of Course
Yes, Planned
Unknown
Too Early to assess, per protocol
Dose change from TAC entered on Course Initiation CRF ?
Minimal/Marginal Response
Stable DiseaseProgressive Disease
Disease Unchanged
Response Assessment
Form
3
COURSE ASS (v2, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
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POSTCHEMOIMGFLT3
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?COMMENTS
Date Notes
Form
3
COURSE ASS (v2, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
POSTCHEMOIMGFLT3
d4.265
VCU_FLT_8029
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
COURSE ASS (v2, 13-APR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of65
POSTCHEMOIMGFLT3
VCU_FLT_8029
d4.3
Visit Name
CRF BlankStudy
Visit Date
Patient
mm x
YESNOCT scan
mm
mmmm
Lesion ID
mm x
Location Measurement 1 Measurement 2
mm
Date of Imaging
mm xmm
mm xmm x
mm x
mm
mm
Lesion ID
mm x
Date of Imaging
mm xmm xmm x mm
Location Measurement 1 Measurement 2
mm
mm
YESNOMRI
mm
mm
mm x
LocationLesion IDDate of Imaging Measurement 2Measurement 1
mm x
mm x
mmmm x
YESNOUltrasound
mmmm x
mm
mm x
Was a mammogram performed No Yes
Date of Imaging Lesion ID
mm
mmmm
mm x
mm xmm x
mmmm x
mm
Measurement 2Measurement 1Location
Form
1
OTHER IMAG (v1, 15-MAR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
Other Imaging
POSTCHEMOIMGFLT3
d5
VCU_FLT_8029
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Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
LOQ
NO
T1cTis
PN0(I-)T4aTis (Paget's)
LIQYES
TXT1a
PN0(I+)T4Tis (LCIS)
Residual Invasive Carcinoma
NO
T4dT1
PN0T3
Finding
Quadrant
T Stage
UOQ
T2
T4cT0
Residual In Situ Carcinoma
Site
N Stage
UIQ
YES
T1bT1mic
T4bTis (DCIS)
M Stage
PNXPN1B
PN2BM1
PN1APN3C
PN2AM0
PN3BPN1
PN2MX
PN3APN0(MOL-)
PN1MI
PN1C
PN3PN0(MOL+)
OtherModified Radical MastectomyLumpectomy Simple MastectomyLEFT RIGHT
Lesion ID
ProcedureDate of Surgical Resection
Surgical Pathology
TA: Target LesionNT: Non- Target Lesion
Diameter 2 (cm)Diameter 1 (cm)Status
POS / NEG
Form
3
SURGICAL P (v1, 03-SEP-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
70
SURGICAL RESECT
VCU_FLT_8029
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Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
COMMENTS
Date Notes
Form
3
SURGICAL P (v1, 03-SEP-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
70
SURGICAL RESECT
VCU_FLT_8029
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Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
SURGICAL P (v1, 03-SEP-2009)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
SURGICAL RESECT
e1.3
VCU_FLT_8029
70
Visit Name CRF Blank
Study
Visit Date
Patient
Section blank?
Total # of CellsMitotic Count #YesNoLesion ID#Analyzed
PROLIFERATION INDEX - POST-TREATMENT
% Positive Cells
HPF 4
Yes
HPF 9
No
HPF10
HPF 3
Biomarker Name
HPF 6
Sample Collection Date
Staining Grade
HPF 1
Analyzed
Pathology #
HPF 2
HPF 8
1
HPF 7
0 2
HPF 5
Pathological Response
Mitotic Index (% labeled)
2
POSTPROLIF (v1, 03-SEP-2009)Doc#
Visit# CRF Page
FormStatus
Subevent#of
Note: Dates will appear as 'DD-MON-YYYY'
SURGICAL RESECT
VCU_FLT_8029
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Visit Name CRF Blank
Study
Visit Date
Patient
Section blank?
NoteDate
COMMENTS
2
POSTPROLIF (v1, 03-SEP-2009)Doc#
Visit# CRF Page
FormStatus
Subevent#of
Note: Dates will appear as 'DD-MON-YYYY'
70 e2.2
SURGICAL RESECT
VCU_FLT_8029
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Slides
ALL study participants' personal identifying information (participant name, medical record number, SS#, etc.) on all
Timepoint in study: (select one) POST (VISIT 5)PRE (VISIT 1)
Were slides paraffin blocks able to be sent? (select one)
Date Form Completed
Number of slides
Specimen lost
Initials of Person from Site Completing This Form
Not allowed by institution
Date slides blocks reports Sent to Path Lab
Tumor Slides Transmittal Form
Provide reason unable to send slides paraffin blocks
Type of tissue submitted: (check all that apply)
Date of surgical procedure
Yes
Other, specify
number of blocks
Other, specify
No
Richmond, VA 23298-0470
RE: ACRIN 6688 Pathology
P.O. Box 980470
of the material is de-identified
1101 East Marshall Street, Room 4-065
Each slide block report is labeled with the study number, site number, patient case number and pre or post timepoint.
Virginia Commonwealth University Health System
(complete then intial, sign and date form and send to address listed below along with reports)
Part A. Completed by Site RA
The pathology specimens, pathology report, imaging report and this form should be shipped to the central pathology
Megan Quinnlaboratory to:
Paraffin block(s)
Before Sending the Slides Blocks and reports, please check to confirm:
Form
4
TUMOR_SLID (v2, 02-SEP-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
SURGICAL RESECT
VCU_FLT_8029
e3.170
Visit Name
CRF BlankStudy
Visit Date
Patient
Have specimen(s) been received in an acceptable condition?
Date Form Completed
Number of blocks received
Initials of Person from Site Completing This Form
Number of slides received
Yes
Date Slides Blocks Received
No
Part B. Completed by VCU Path Lab
Form
4
TUMOR_SLID (v2, 02-SEP-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
e3.2
SURGICAL RESECT
70
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
NotesDate
COMMENTS
Form
4
TUMOR_SLID (v2, 02-SEP-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'
e3.3
SURGICAL RESECT
70
VCU_FLT_8029
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
4
TUMOR_SLID (v2, 02-SEP-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
SURGICAL RESECT
VCU_FLT_8029
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Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
%
Residual Cancer Burden
Diameter of largest metastasis
mm
Residual Cancer Burden (Surgical Resect time point)
mm
Calculations:
%
mm x
1) Primary Tumor Bed
2) Lymph Nodes
Primary Tumor Bed Area
Overall Cancer Cellularity (as percentage of area)
Percentage of Cancer that is in situ disease
Number of Positive Lymph Nodes
Form
3
RESIDUAL C (v1, 11-MAR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
70
SURGICAL RESECT
e4.1
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
NotesDate
COMMENTS
Form
3
RESIDUAL C (v1, 11-MAR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
e4.2
SURGICAL RESECT
70
VCU_FLT_8029
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
RESIDUAL C (v1, 11-MAR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
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SURGICAL RESECT
Visit Name
CRF BlankStudy
Visit Date
Patient
Complicating Disease, Intercurrent Illness
No Treatment, per protocol
Refused further Treatment
Patient Noncompliance
Protocol Violation
Disease Progression On Study
PI DiscretionTreatment Period Completed
Not Treated - Other Reasons, explainOther
Adverse Events, Side Effects
Late Determination of Ineligibility
Lost to Further Follow-up
Cytogenetic resistanceDeath on StudyDisease Progression before TreatmentSwitched to Alternative Treatment
Date will be displayed as 'DD-MON-YYYY'
Patient Declined to Participate (before treatment started)
OFF TREATMENT SUMMARY
Explain 'Other' Reason Off Treatment
Reason Off Treatment
Date Off Treatment
Form
1
OFF TREAT (v1, 11-MAR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
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OFF-TREATMENT
Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
Explain 'Other' Reason
Patient NoncomplianceLost to Further Follow-upNot Treated - Other Reasons, explainToxicity
Reason Off Study
Date of Disease Progression
OFF STUDY SUMMARY
Study CompleteDeath on Study
Other
Complicating Disease / Intercurrent Illness
Date Off Study
Form
3
OFF STUDY (v1, 11-MAR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
OFF-STUDY
VCU_FLT_8029
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Visit Name
CRF BlankStudy
Visit Date
Patient
Section blank?
COMMENTS
Date Notes
Form
3
OFF STUDY (v1, 11-MAR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
Note: Dates will appear as 'DD-MON-YYYY'
VCU_FLT_8029
g1.290
OFF-STUDY
Visit Name
CRF BlankStudy
Visit Date
Patient
Note
COMMENTS
Date
Form
3
OFF STUDY (v1, 11-MAR-2010)Doc#
Visit# CRF Page
Status
DCI DateSubevent# of
VCU_FLT_8029
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OFF-STUDY
Visit Name CRF Blank
Study Patient
Section blank?
Stop Date
CONCOMITANT MEASURES/MEDICATIONS
Agent NameStart Date ProcedureDoseUnits
DailyDose
Total
Schedule Route Reason
2
CONCOMITAN (v1, 10-SEP-2009)Doc#
Visit# CRF Page
FormStatus
Subevent# of
Note: Dates will appear as 'DD-MON-YYYY'
h1.1
VCU_FLT_8029
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CONMED
Visit Name CRF Blank
Study Patient
Section blank?
NoteDate
COMMENTS
2
CONCOMITAN (v1, 10-SEP-2009)Doc#
Visit# CRF Page
FormStatus
Subevent# of
Note: Dates will appear as 'DD-MON-YYYY'
h1.2
CONMED
VCU_FLT_8029
100
Visit Name CRF Blank
Study Patient
Section blank?
Y/ N / U
ReportExpedited
Filed?System Organ Class (SOC) AE DescriptionDate of Onset Date Resolved CTC Term
ADVERSE EVENTS
Grade:1 =Mild2=Moderate3=Severe4=Threat5=Fatal
Attribution:1=Unrelated2=Unlikely3=Possible4=Probable5=Definite
Therapy:1=None2=Symptom3=Support4=Vigorous
Serious:1=No2=Threat3=Death4=disability5=Hospital6=Anomaly7=Requires Intervention
Action:1=None2=Reduced3=Interrupt4=Discontinued5=Interrupt/Reduced
Outcome:1=Recovered2=Treatment3=Alive4=Died
4
AE (v1, 22-JAN-2010)Doc#
Visit# CRF Page
FormStatus
Subevent# of
Note: Dates will appear as 'DD-MON-YYYY'
AE
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Visit Name CRF Blank
Study Patient
Date of Onset AE DescriptionDate Resolved
ReportExpedited
Attribution:1=Unrelated2=Unlikely3=Possible4=Probable5=Definite
Serious:1=No2=Threat3=Death4=disability5=Hospital6=Anomaly7=Requires Intervention
Grade:1 =Mild2=Moderate3=Severe4=Threat5=Fatal
Therapy:1=None2=Symptom3=Support4=Vigorous
Filed?
Action:1=None2=Reduced3=Interrupt4=Discontinued5=Interrupt/Reduced
Outcome:1=Recovered2=Treatment3=Alive4=Died
Y/ N / UCTC Term System Organ Class (SOC)
4
AE (v1, 22-JAN-2010)Doc#
Visit# CRF Page
FormStatus
Subevent# of
AE
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Visit Name CRF Blank
Study Patient
Action:1=None2=Reduced3=Interrupt4=Discontinued5=Interrupt/Reduced
Serious:1=No2=Threat3=Death4=disability5=Hospital6=Anomaly7=Requires Intervention
AE Description
Grade:1 =Mild2=Moderate3=Severe4=Threat5=Fatal
ExpeditedReport
Date Resolved
Outcome:1=Recovered2=Treatment3=Alive4=Died
Filed?Y/ N / UCTC Term
Therapy:1=None2=Symptom3=Support4=Vigorous
Attribution:1=Unrelated2=Unlikely3=Possible4=Probable5=Definite
Date of Onset System Organ Class (SOC)
4
AE (v1, 22-JAN-2010)Doc#
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FormStatus
Subevent# of
AE
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