Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging

Summary

Background: Injury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help. Objective: To test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease. Eligibility: People aged 18 years and older with lung or heart disease that may cause scarring in those organs. Design: Participants will have 6 clinic visits over 2 years. Participants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart. The study tracer will be used with positron emission tomography (PET)/computed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine. Participants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits. Participants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated....

Detailed Description

Study Description: Fibroblast activation protein-targeted PET detects activated fibroblasts in a range of inflammatory and fibrosing cardiovascular and pulmonary disorders. It is a sensitive and quantifiable intervention to diagnose and monitor the natural history of cardiopulmonary disorders and/or the effects of antifibrotic interventions. Objectives: Primary objective: To compare 18F-FAPI-74 PET/CT to standard of care (SOC) imaging (18F-FDG-PET/CT, non-contrast chest CT, and cardiac MRI for heart cohort) to detect fibrosis. Secondary objective: To compare the ability of 18F-FAPI-74 PET/CT imaging to assess the natural history or treatment responses with standard of care imaging in cardiopulmonary diseases associated with fibrosis. Exploratory objectives: To use high density proteomic, transcriptomic, and metagenomic analysis of specimens from lung and/or blood to define associated mechanisms and biomarkers of active fibrosis with the visualization and quantification of FAP expression. Endpoints: Primary: Compare 18F-FAPI-74 PET/CT to standard of care (SOC) imaging with 18F-FDG-PET/CT (with the rate of concordance defined as a quantitative measure of the abnormal lung parenchyma detected in both the FAPI and FDG PET scans ranging from 0 to 100%) and cardiac MRI for heart cohort for the development of pulmonary or cardiovascular fibrosis at baseline These findings will be evaluated separately in six different at-risk cohorts (allogeneic stem cell transplant, lung allograft transplant, interstitial lung disease, acute lung injury, pulmonary arterial hypertension, and cardiovascular disease). Secondary: Compare the ability of 18F-FAPI-74 PET/CT imaging to assess the progression of fibrosis or treatment response compared to SOC imaging. The magnitude of change in 18F-FAPI-74 PET/CT uptake (SUVmax and mean/median) between scans one and two will be compared. Comparisons of the quantitative chest CT abnormalities will be compared to both 18F-FAPI-74 PET/CT and 18F-FDGPET/CT scans. These findings will be evaluated separately in six different at-risk cohorts (allogeneic stem cell transplant, lung allograft transplant, interstitial lung disease, acute lung injury, pulmonary arterial hypertension, and cardiovascular disease). Comparison of 18F-FAPI-74 PET/CT to standard of care (SOC) imaging at up to 12 months after the initial scan at baseline and change from the baseline. Exploratory: To use high density proteomic, transcriptomic, and metagenomic analysis of specimens from lung and/or blood to define associated biomarkers and mechanisms of active fibrosis with the visualization and quantitation of FAP expression.

Eligibility Criteria

Interventions