Radiation Protection in Radionuclide TherapyPart 8IAEA Training Material on Radiation Protection in Nuclear Medicine

Part 8. Therapy

Nuclear Medicine

Part 8. Therapy*ObjectiveTo be able to apply the principle of optimization of radiation protection to therapeutic procedures including design, operational consideration, quality control and clinical dosimetry.

Part 8. Therapy

Nuclear Medicine

Part 8. Therapy*ContentsBasic requirementsAdministration of therapyThe radioactive patient. Dose constraintsThe hospitalized patientEmergency procedures

Part 8. Therapy

Module 8.1 Basic RequirementsPart 8Optimization of Protection in Medical ExposureIAEA Training Material on Radiation Protection in Nuclear Medicine

Part 8. Therapy

Nuclear Medicine

Part 8. Therapy*Justification of Medical Exposure (BSS: Interim Edition, 2011)3.154. Medical exposures shall be justified by weighing the expected diagnostic or therapeutic benefits that they yield against the radiation detriment that they might cause, with account taken of the benefits and the risks of available alternative techniques that do not involve medical exposure.

Use WHO guidelines

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Nuclear Medicine

Part 8. Therapy*Responsibilities (BSS: Interim Edition)3.164. For therapeutic radiological procedures in which radiopharmaceuticals are administered, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, and if appropriate with the radiopharmacist or radiochemist, shall ensure that for each patient the appropriate radiopharmaceutical with the appropriate activity is selected and administered so that the radioactivity is primarily localized in the organ(s) of interest, while the radioactivity in the rest of the body is kept as low as reasonably achievable.

Part 8. Therapy

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Part 8. Therapy*Dosimetry (BSS: Interim Edition)3.167. Registrants and licensees shall ensure that dosimetry of patients is performed and documented by or under the supervision of a medical physicist, using calibrated dosimeters and following internationally accepted or nationally accepted protocols, including dosimetry to determine the following:..(c) For therapeutic medical exposures, absorbed doses to the tissues or organs for individual patients, as determined to be relevant by the radiological medical practitioner.

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Part 8. Therapy*Medical PhysicistA qualified medical physicist should be responsible for measurement of radionuclide activity, identification ofradionuclides and internal radiation dosimetry

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Part 8. Therapy*Absorbed Dose-Administered ActivityI-131Activity (MBq)=

23.4*mass(g)*dose (Gy)uptake at t=0 (%)*Teff (d)Berg GEB et al, J Nucl Med 1996; 37:228-232Example of method to calculate administered activity fromPrescribed absorbed dose to the thyroid

Part 8. Therapy

Sheet: jod

Sheet: program

S k a r a b o r g

SPRJODUNDERSKNING

Patientnamn:

NN

Fdelsenummer:

400928-3336

Underskningsdag:

1997-10-19

Sprdos (MBq):

0.025694444444444447

Thyroid mass (g)

30.0

Prescibed dose (Gy)

100.0

Uptake measurements

Time

Standard

Patient

Bg

Uptake

(h)

(cpm)

(cpm)

(cpm)

(%)

0.0

-

-

-

73.5120544433593

25.0554637908935

67.2935256958007

61.324348449707

43.256061553955

Effective half-life (d):

3.97240479120097

Activity to administer (MBq):

240.394792122319

Aktivitet, gammal metod (MBq):

164.949003417912

S k a r a b o r g

Nuclear Medicine

Part 8. Therapy*Uptake Measurement

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Part 8. Therapy*Gamma Camera Examination

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Part 8. Therapy*Gamma Camera ExaminationUsed to determine the size of the organ

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Part 8. Therapy*Safe handling ofradionuclidesorderingreceipt and unpackingstoragedispensinginternal transportsradioactive wasteSafe administrationIdentificationpregnancybreastfeedingFactors Affecting Safety in Radionuclide TherapyPatient preparationThe radioactive patient and dose constraintsThe hospitalized patientinstructions to nursing staffvisitors instructionsdischarge of the patientdecommissioning of hospital wardradioactive wasteEmergency procedures

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Part 8. Therapy*The hospital routines for ordering radionuclides should be followed.When ordering, be sure the delivery service knows where in the hospital to deliver the material.Make sure that the package is expected and that no un- authorized person will open it upon arrival.Before unpacking, check the package. In case of damage, contact your RPO.Ordering, Receipt & Unpacking

Part 8. Therapy

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Part 8. Therapy*The radionuclide should be stored in a controlled area, according to national regulations and local rules.

The radionuclide should always be stored in a lead container and preferably in a fridge to prevent evaporation

To reach an acceptable external dose rate, a thickness of 1-4 cm lead is generally required.

Storage of I-131

Part 8. Therapy

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Part 8. Therapy* Protective clothing Lead shields (bench top shield, vial shield, syringe shield) Keep the vial in the fume hood and on a tray with lips, lined with plastic backed absorbent pads. Handle the vial with forceps or similar long handled instruments. Cover the vial with lead after use. Check the activity Fill in the necessary recordsDispensing

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Part 8. Therapy*Internal TransportIf the administration of radiopharmaceutical to the patient takes place far from the dispensing room, use a transport container withabsorbent pads.

Make sure that a warning sign is on the container togetherwith patient name, activity and date.

Travel by the most direct route avoiding more heavilyoccupied areas

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Part 8. Therapy*Radioactive WasteShall be collected, segregated and disposed of according to national regulations and local rules.

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Module 8.2 Administration of TherapyPart 8Optimization of Protection in Medical ExposureIAEA Training Material on Radiation Protection in Nuclear Medicine

Part 8. Therapy

Nuclear Medicine

Part 8. Therapy*

Be prepared for an emergency situation.Careful identification of the patient (hospital routines shall be followed).Questions to the patient:-Pregnant?-Breastfeeding?-Incontinent?-Nausea?-Living conditions?-Type of work?-Public transportation back home?Verbal and written individual instructions to the patient.Precautions Before Administration

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Part 8. Therapy*3.175. Registrants and licensees shall ensure that there are procedures in place for ascertaining the pregnancy status of a female patient of reproductive capacity before the performance of any radiological procedure that could result in a significant dose to the embryo or fetus, so that this information can be considered in the justification for the radiological procedure (para. 3.154 and 3.156) and in the optimization of protection and safety (para. 3.165).

Pregnancy (BSS: Interim Edition)

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Part 8. Therapy*Radioiodine Therapy and PregnancyRadioiodine easily crosses the placenta and therapeutic doses can pose significant problems for the fetus, particularly permanent hypothyroidism.

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Part 8. Therapy*Radioiodine TherapyAs a rule, a pregnant woman should not be treated with a radioactive substance unless the therapy is required to save her life: in that extremely rare event, the potential absorbed dose and risk to the fetus should be estimated and conveyed to the patient and the referring physician. Considerations may include terminating the pregnancy.

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Part 8. Therapy*Radioiodine TherapyIn women, thyroid carcinoma comprises over 80% of cancer of the head and neck diagnosed between the ages of 15-45 years. Thyroid cancers are relatively unaggressive compared to most other cancers. As a result both surgical and radio-iodine treatment are often delayed until after pregnancy. In general, if any therapy is to be performed during pregnancy, it will be surgery during the second or third trimester.

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Part 8. Therapy*Inadvertent Administration of Therapy DoseMenstrual history is often not adequate to ensure that a patient is not pregnant. In most developed countries, it is common practice to obtain a pregnancy test prior to high-dose 131 I scanning or therapy for women of childbearing age unless there is a clear history of prior tubal ligation or hysterectomy precluding pregnancy. In spite of the above, it still happens that pregnant women are treated, either because of false histories or because the pregnancy is at such an early stage that the pregnancy test is not yet positive.

Part 8. Therapy

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Part 8. Therapy*Becoming Pregnant after Irradiation ICRP has recommended that a woman not become pregnant until the potential fetal dose from remaining radionuclides is less than 1 mGy.

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Part 8. Therapy*Pregnancy after TherapyRadiopharmaceutical All activities Avoid pregnancy up to (MBq) (months)Au-198 colloid10000 2I-131 iodide (thyroid ca) 5000 4I-131 iodide (thyrotoxicosis) 800 4I-131 MIBG 5000 4P-32 phosphate 200 3Sr-89 chloride 150 24Y-90 colloid (arthritic joints) 400 0Y-90 colloid (malignancy) 4000 1

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Part 8. Therapy*3.176. Registrants and licensees shall ensure that there are arrangements in place for establishing that a female patient is not breast-feeding before the performance of any radiological procedure involving the administration of a radiopharmaceutical that could result in a significant dose to an infant being breast-fed, so that this information can be considered in the justification for the radiological procedure (para. 3.154 and 3.156) and in the optimization of protection and safety (para. 3.165).

Breast Feeding (BSS: Interim Edition)

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Part 8. Therapy*Breast Feeding

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Part 8. Therapy*Patient Information Needed:Nausea-intravenous administration to be considered?Living conditions-number of people in house? -children? -separate room?Type of work-working close to other people? -working with children?-pregnant coworkers?Public transport-time?

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Part 8. Therapy*Administration of Therapy:Calibration of Sources (BSS)3.166. In accordance with para. 3.153(d) and (e), the medical physicist shall ensure that:(a) All sources giving rise to medical exposure are calibrated in terms of appropriate quantities using internationally accepted or nationally accepted protocols;3.164. For therapeutic radiological procedures in which radiopharmaceuticals are administered, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, and if appropriate with the radiopharmacist or radiochemist, shall ensure that for each patient the appropriate radiopharmaceutical with the appropriate activity is selected and administered so that the radioactivity is primarily localized in the organ(s) of interest, while the radioactivity in the rest of the body is kept as low as reasonably achievable.

Part 8. Therapy

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Part 8. Therapy*I-131 should be administered in a controlled area (hot lab or the patients hospital bedroom).A plastic bag for contaminated items should be available as well as paper tissues.The patient is asked to sit at a table covered with adsorbent pads and the floor beneath the patient should also be covered by adsorbent pads.If the I-131 is administered in capsules they should be transferred to the patient mouth by tipping from a small shielded (>1 cm Pb) container.I-131 administered in an oral solution (50 ml) should be sucked up through a straw from the shielded vial by the patient. The vial should be flushed with water several times. The patient should drink several glasses of water to clean the mouth.

Safe Administration

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Part 8. Therapy*Safe Administration

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Part 8. Therapy*Procedure for intravenous administration:

Dispense the radionuclide into a shielded syringePut the radionuclide in an infusion bottleLine the bottle to the patient using an intravenous catheterKeep the patient in bed until the bottle is emptyRemove the bottle and the catheter and dispose of them as radioactive wasteSafe Administration

Part 8. Therapy

Module 8.3 The Radioactive Patient: Dose ConstraintsPart 8Optimization of Protection in Medical ExposureIAEA Training Material on Radiation Protection in Nuclear Medicine

Part 8. Therapy

Nuclear Medicine

Part 8. Therapy*Shall the Patient be Hospitalized?Can the patient leave?Any restrictions?

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Part 8. Therapy*Dose Constraints(BSS: Interim Edition) 3.172. Registrants and licensees shall ensure that relevant dose constraints (para. 3.148(a)(i)) are used in the optimization of protection and safety in any procedure in which an individual acts as a carer or comforter.

Part 8. Therapy

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Part 8. Therapy*Dose Limitation for Comforters and Visitors of Patients ..The dose shall be constrained so that it is unlikely that his orher dose will exceed 5 mSv during the period of a patientsdiagnostic examination or treatment. The dose to childrenvisiting patients who have ingested radioactive materials shouldbe similarly constrained to less than 1 mSv

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Part 8. Therapy*Exposures From Patient1000 MBqI-1310 0.5 1 2 m0.5 0.1 0.06 0.03 mSv/h Contamination External

saliva perspiration breath urine

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Part 8. Therapy*Biodistribution of I-131(MIRD)

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Part 8. Therapy*Excretion of I-131

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Part 8. Therapy*ContaminationExcretion Concentration Contamination

Saliva

Module 8.4The Hospitalized PatientPart 8Optimization of Protection in Medical ExposureIAEA Training Material on Radiation Protection in Nuclear Medicine

Part 8. Therapy

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Part 8. Therapy* separate room with toilet and shower patient instructions (verbal and written) local rules for nursing the patient local rules for visitors local rules for decontamination local rules for emergency situationsHospitalized Patient

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Part 8. Therapy*Room for Iodine Therapy(controlled area) only one patient in the room easily cleanable surfaces and utensils extra lead shields door closed warning sign outside restrictions for visitors decontamination equipment

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Part 8. Therapy*Isolation WardAreas are covered with plastic backed absorbent material.Bed shield is positionedKing Faisal Specialist Hospital and Research Center, Riyadh

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Part 8. Therapy*Warning Signs Radiation sign posted on doorand on Patient ChartKing Faisal Specialist Hospital and Research Center, Riyadh

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Part 8. Therapy*Stay in the room.Drink as much as possible.Eat lemon slices.Use only the private toilet and flush 3 times. (Men should sit down to avoid splashing.)Wash hands well in soapy water after using toilet.Wear footwear when leaving the bed.In event of vomiting or incontinence notify the nurse immediately.Patient Instructions

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Part 8. Therapy*Reduce time spent with patient by planning ahead and working efficiently.Work as far from patient as possible.Practice preventative measures against contamination. -wear impermeable protection gloves-wear shoe covers-wear a protective gown Remove protection clothing before leaving the room.Instructions to Nursing Staff

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Part 8. Therapy*The patient you are about to visit has received a therapeutic doseof radioactive iodine. It is in your own best interest to protect yourselfas much as possible from receiving more radiation than is necessary.To assist you in meeting that end we offer the following recommendations:

Visitors are discouraged for a 48 hour period after the patient receives the treatment.Pregnant women and children under the age of 18 are not permitted to visit.You should keep your visit short (

Typical Graph Showing the Percentage of Patients per Range of Activity of I-131

Chart9

12

16

18

17

16

17

24

16

11

15

15

14

Total = 191

Month

No.of Patients

I-131 Patients Admitted Monthly for Year 2000

Sheet1

Male77%

Female23%

1991199219931994199519961997199819992000

63158125147166140162177211191

10

28199163

31421992158

4311993125

5101994147

1995166

1996140

113.321997162

23.71998177

31.541999211

41.32000191

1100< 500

22450-9913

310100-14963

49150-19989

200&>26

1%12

8%16

34%18

45%17

12%16

17

24

16

11

15

15

14

Sheet2

Sheet3

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Part 8. Therapy*Discharge of PatientAbdalla Al-Haj

Part 8. Therapy

Chart1

0.77

0.23

Female

Male

Profile of the Patients Admitted According to Sex

23%

77%

Chart2

63

158

125

147

166

140

162

177

211

191

991 1992 1993 1994 1995 1996 1997 1998 1999 2000

Year

Number of Patients

10- Year Profile of the Total Number of Patients Admitted for I-131 Therapy

Chart3

0

8

142

31

10

(4%)

(75%)

(16%)

(5%)

Number of Days of Isolation

Number of Patients

Graph Showing the Number of Patients (5GBq) and the Number of Days of Isolation(Year 2000 Statistics)

Chart4

Chart5

13.32

3.7

1.54

1.3

Days of Isolation

Exposure Rate (mR/hr)

Typical Graph of the Exposure Rate per Day at 1 m Distance from the Patient Administered with 150 mCi of I-131

Chart6

100

24

10

9

Day of Isolation

Percentage of I-131 in Body

Typical Graph Showing the Percentage of I-131That is Retained in the Body Per Day in a Patient Administered with 150mCi

Chart7

0

13

63

89

26

Range of Activity (mCi)

Number of Patients

Typical Graph Showing the Number of PatientsPer Range of Administered Activity of I-131

Chart8

0.01

0.08

0.34

0.45

0.12

< 50mCi

50-99mCi

100-149 mCi

150-199mCi

200 mCi &>

Typical Graph Showing the Percentage of Patients per Range of Activity of I-131

Chart9

12

16

18

17

16

17

24

16

11

15

15

14

Total = 191

Month

No.of Patients

I-131 Patients Admitted Monthly for Year 2000

Sheet1

Male77%

Female23%

1991199219931994199519961997199819992000

63158125147166140162177211191

10

28199163

31421992158

4311993125

5101994147

1995166

1996140

113.321997162

23.71998177

31.541999211

41.32000191

1100< 500

22450-9913

310100-14963

49150-19989

200&>26

1%12

8%16

34%18

45%17

12%16

17

24

16

11

15

15

14

Sheet2

Sheet3

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Part 8. Therapy*DecontaminationThe RPO should supervise the removal of contaminated waste, the decontamination of the room and equipment and should make a documented final survey of the room.

Monitoring and decontamination must be done prior to entry of nursing and housekeeping staff to prepare the room for the next patient.

When survey and decontamination procedures are complete, the RPO will remove the radiation warning sign and notify the nursing and housekeeping staff that the room is now clear for general use.

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Part 8. Therapy*MonitoringFurniture and telephone sets are surveyed.Areas suspected to be contaminated are surveyed.King Faisal Specialist Hospital and Research Center, Riyadh

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Part 8. Therapy*MonitoringDerived limit: 3 Bq/cm2

METHODS wipe testing direct surveying

Part 8. Therapy

Area or item

Initial

(Bq/cm2)

After cleaning

(Bq/cm2)

Toilet

Washroom floor

Sink and Faucets

Shower

Bed

Armchair

Bedroom floor

TV/Telephone

Bedside table

Doorknobs

Lamp switches

Nuclear Medicine

Part 8. Therapy*Ready for a New PatientA Radiation Safe sign is posted at the door after decontamination and clearing of roomKing Faisal Specialist Hospital and Research Center, Riyadh

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Part 8. Therapy*Faeces, urine and other liquids should be disposed of via the toilet.

Contaminated clothing, linen, food items etc which can not go into the toilet should be stored in a separate plastic bag labeled RADIOACTIVE, and should be removed daily to the designated radioactive waste storage facility.

Disposable cutlery and dishes should be used. If not, they should be washed in the patients room and reused by the patient.Radioactive Waste

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Part 8. Therapy*Radioactive WasteAll patient radioactive wastes are placed in a plastic bag and the bag is properly tagged.

Part 8. Therapy

Module 8.5 Emergency Procedures:Death of PatientPart 8Optimization of Protection in Medical ExposureIAEA Training Material on Radiation Protection in Nuclear Medicine

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Part 8. Therapy*HELP!

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Part 8. Therapy*Safety AssessmentContingency PlanA safety assessment will reveal the possiblesituations where emergency actions have to be taken:

Loss or damage of radioactive materialSpillage of radioactive materialFireMedical emergencies...A detailed contingency plan covering actions tobe taken in any foreseeable accident should beavailable.

Part 8. Therapy

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Part 8. Therapy*In the event of death of a patient who has recently received a therapeutic dose of a radionuclide care has to be taken toensure that personnel receive as low a dose as possible at all stages prior to the burial or cremation. Death of PatientActivity (MBq)(UK)

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Part 8. Therapy*Precautions that should be given are depending on the residual activityand the expert advice provided by the RPO and may involve the following:

preparation for burial or cremation should be controlled by a competent person, relatives should be prevented from coming into close contact with the body, people should not be allowed to linger in the presence of the coffin, all personnel involved in handling the corpse should be instructed by the RPO and monitored if appropriate, all objects, clothes, documents etc that might have been in contact with the deceased must be tested for contamination, it may be expedient to wrap the cadaver in waterproof material immediately after death to prevent spread of contaminated body fluids, embalming of cadavers should, if possible, be avoided, autopsy of highly radioactive cadavers should be restricted to the absolute minimumDeath of Patient

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Part 8. Therapy*Questions?

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Part 8. Therapy*DiscussionDiscuss the advantages/disadvantages of giving the patient a standard activity of I-131 in a capsule or giving a carefully calculated activity based on a prescribed dose to the thyroid.

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Part 8. Therapy*DiscussionWho should prescribe a thyroid treatment with I-131?Who should perform the treatment?

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Part 8. Therapy*DiscussionDefine some emergency situations or other hazardous events that can occur in an isolation ward and how to handle the situations.

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Part 8. Therapy*Where to Get More InformationOther sessions Part 6 Medical exposure Part 5 Occupational exposure Part 4 DesignFurther readings IAEA, International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources Safety Series No.115, Interim Edition (2011) IPEM, Medical and Dental Guidance Notes. A good practice guide to implement ionising radiation protection legislation in the clinical environment IAEA/WHO Manual on Radiation Protection in Hospitals and General Practice, Volume 4, Nuclear Medicine IAEA, Manual on therapeutic use of iodine-131. Practical Radiation Safety Guide

Part 8. Therapy

This is just an example of a method to calculate the relation between the prescribed dose and the resulting administered activity. There are several other methods. The image can be used to start a discussion about what should be prescribed by the physician: activity or dose?

An uptake measurement should be used in order to calculate the administered activityA gammacamera examination of the thyroid will give an estimate of the sixe of the organThis is an example of an application programme that calculate the size of the organ and the uptake of Tc99m-pertechnetate.The image describes the safety equipment and precautions for safe dispensing of iodine-131. Note the extra thick shielding necessary because of the high energy photons from the radionuclideThis image shows the uptake of pertechnetate in the breast of a lactating women scheduled for a thyroid scan. The activity in the breasts is about 50% of the administered. The thyroid has an uptake of 1-2%.Discuss with the students why all this information is necessaryWell illuminated, shielded container, table covered with absorbing paper, no hands on the table, patient clothes are protected.Should a radioactive patient (diagnostics, therapy) be placed together with other patients?This is one example of behaviour restrictionsAnd another oneThis is the result of measurements of the effective dose to members of the family of therapy patients. They were all given restrictions according to previous images. Note that all values are lower than the given dose constraints and that there was no correlation between the administered activity and the dose. Social factors are more important.This is an illustration of how a flexible system can be introduced for patients undergoing a iodine therapyIf the activity is >1100 MBq, the patient should always be hospitalizedBetween 600-1100MBq the patients condition and social life determines if he/she should be hospitalized or not.Between 150-600 MBq the patient is always released and is given personal advice and restrictions.Below 150 MBq the patient is given only general advice of behavior restrictions regarding contact with children and pregnant women.This is an example of a form that should be filled in for every released patient giving the necessary information to the family membersIn some hospitals visitors are not allowed at any timeThe measurements should be documented