CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory...

17
FLUIDDA A Respiratory Solutions Company CLINICAL TRIALS CLINICAL PRACTICE FUNCTIONAL RESPIRATORY IMAGING

Transcript of CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory...

Page 1: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

FLUIDDAA Respiratory Solutions Company

CLINICAL TRIALS

CLINICAL PRACTICE

FUNCTIONAL RESPIRATORY IMAGING

Page 2: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

FUNCTIONAL RESPIRATORY IMAGING (FRI)

Proprietary Backbone of the Respiratory Solutions

1 Image Acquisition 2 Structure Segmentation 3 Flow Simulations

Page 3: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

LUNG STRUCTURE LUNG FUNCTION EXPOSURE TO INHALED PARTICLES

Lung and Lobar Volumes Airway Volumes

Airway Wall

VolumeBlood Vessel

Volume

Emphysema

Internal Airflow

Distribution

Air trapping

Ventilation/Perfusion

reserve

Airway Resistance at

FRC and TLC

Aerosol Deposition

FUNCTIONAL RESPIRATORY IMAGING ENDPOINTS

Page 4: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

CONVENTIONAL RESPIRATORY MEDICINE

FEV1 = 85%p

Page 5: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

QUANTITATIVE IMAGING IN RESPIRATORY MEDICINE

Page 6: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

MACHINE LEARNING IN RESPIRATORY MEDICINE

EXACERBATION RISK

MACHINE LEARNING

Page 7: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

MACHINE LEARNING IN RESPIRATORY MEDICINE

Predicting imminent COPD exacerbations

Predicting treatment response in Idiopathic Pulmonary Fibrosis

Predicting lung transplant rejection

Page 8: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

MACHINE LEARNING IN RESPIRATORY MEDICINE

Predicting imminent COPD exacerbations

Predicting treatment response in Idiopathic Pulmonary Fibrosis

Predicting lung transplant rejection

Page 9: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

n = 62 COPD patients

94 HRCT and Clinical parameters

No baseline spirometry parameters could predict imminent exacerbations

Using baseline HRCT scans an imminent exacerbation in COPD patients could be predicted with an accuracy of 81% using

Expiratory scan

Adjusted Airway Volume

Adjusted Airway Resistance

PREDICTING IMMINENT COPD EXACERBATIONSMACHINE LEARNING ON IMAGING PARAMETERS

Lanclus et al. Acad Radiol. 2018 Nov 23. S1076-6332(18)30487-2.

Page 10: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

PREDICTING IMMINENT COPD EXACERBATIONSMACHINE LEARNING ON IMAGING PARAMETERS

Lanclus et al. Acad Radiol. 2018 Nov 23. S1076-6332(18)30487-2.

ADJUSTED AIRWAY VOLUMEADJUSTED AIRWAY RESISTANCE

Page 11: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

PREDICTING IMMINENT COPD EXACERBATIONSMACHINE LEARNING ON IMAGING PARAMETERS

Lanclus et al. Acad Radiol. 2018 Nov 23. S1076-6332(18)30487-2.

STABLEIMMINENT EXACERBATIONS

Page 12: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

MACHINE LEARNING IN RESPIRATORY MEDICINE

Predicting imminent COPD exacerbations

Predicting treatment response in Idiopathic Pulmonary Fibrosis

Predicting lung transplant rejection

Page 13: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

PREDICTING TREATMENT RESPONSE IN IPFMACHINE LEARNING ON IMAGING PARAMETERS

Wu et al. Am J Respir Crit Care Med. 2019 Jan 1;199(1):12-21.

n = 66 IPF patients

16 HRCT and Clinical parameters

Treatment FG3019 for 48 weeks

Using baseline HRCT scans, FVC stability or decline >10%p after 48 week treatment with FG3019 could be predicted with an accuracy of 86.5% using

Inspiratory Scan

Lobe Volumes

Adjusted Airway Volumes

Expiratory Scan

Adjusted Airway Volumes (lower lobes)

Page 14: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

MACHINE LEARNING IN RESPIRATORY MEDICINE

Predicting imminent COPD exacerbations

Predicting treatment response in Idiopathic Pulmonary Fibrosis

Predicting lung transplant rejection

Page 15: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

PREDICTING LUNG TRANSPLANT REJECTIONMACHINE LEARNING ON IMAGING PARAMETERS

Barbosa et al. Acad Radiol. 2018 Sep;25(9):1201-1212.

n = 41 Lung Transplant patients

31 HRCT and Clinical parameters

No baseline spirometry parameters could predict transplant rejection

Using baseline HRCT scans, transplant rejection could be predicted with an accuracy of 85% using

Inspiratory Scan

Lobe Volumes

Adjusted Airway Surface Area

Expiratory Scan

Airway Resistance

Page 16: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

PREDICTING LUNG TRANSPLANT REJECTIONMACHINE LEARNING ON IMAGING PARAMETERS

AIRWAY VOLUME [ml]LOBE VOLUMES [%p]

Barbosa et al. Acad Radiol. 2018 Sep;25(9):1201-1212.

Page 17: CLINICAL PRACTICE CLINICAL TRIALS FUNCTIONAL … · functional respiratory imaging respiratory diseases regulatory treatments clinical trial process asthma copd ipf cf ph sleep apnea

FROM AI-BASED FRI TO RESPIRATORY SOLUTIONS

FUNCTIONAL RESPIRATORY IMAGING

RESPIRATORY DISEASES REGULATORY

CLINICAL TRIAL PROCESSTREATMENTS

ASTHMA

COPD

IPF

CF

PH

SLEEP APNEA

SINUSITIS

BOS

BRONCHODILATORS

MEDICAL DEVICES

ANTI-INFLAMMATORY DRUGS (INC BIOLOGICS)

ANTI-FIBROTIC

MUCOLYTIC

FDA SUPPORT

BIOMARKER QUALIFICATION PROGRAM

NEGOTIATED ENDPOINTS

FLUIDDA SPONSORED TRIALS (n > 10)

FULL SERVICE CRO (n > 10)

IMAGING CRO (n > 25)

RESPONDER PHENOTYPINGCOMPANION DIAGNOSTICS

STOPPING RULES FOR HIGH PRICE TREATMENTSRISK SHARING REAL WORLD EVIDENCE

PAYER ENGAGEMENT

CLINICAL TRIALS

CLINICAL PRACTICE