Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein In… (NCT07613099) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
United States210 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated informed consent form
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Participant \>=18 years old
. Has a specific diagnosis of a cardiopulmonary and/or vascular disease that puts them at risk of developing or having developed tissue fibrosis.
. Has undergone prior imaging of lungs, heart, and/or vasculature with chest CT
. Able to lie on the PET/CT scanner for imaging up to 45 minutes.
. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of FAPI-PET/CT or the FDG PET/CT scan.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing a new PET/CT scan using something called 18F-FAPI-74 to the standard imaging tests I might already be getting — would participating mean I'd need additional scans on top of my usual care, and how would that affect my schedule and radiation exposure?
2Since this trial is still not yet recruiting, how long might it realistically be before I could actually enroll, and is there a standard imaging approach I should be pursuing in the meantime to monitor my condition?
3This study is enrolling people with several different conditions — including interstitial lung disease, pulmonary arterial hypertension, and post-transplant complications — so which patient group would I likely fall into, and does that affect what the trial would actually involve for me?
4Even though this is a Phase 3 trial comparing imaging methods rather than testing a new treatment, could any findings from the 18F-FAPI-74 scan change the way my fibrosis is managed, or would the results mainly be used for research purposes?
5Is there any reason my doctor thinks the standard imaging I'm already receiving might not be giving a complete picture of my fibrosis activity, and would a trial like this one potentially offer more useful information about what's happening in my lungs or heart?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare 18F-FAPI-74 PET/CT to standard of care imaging (non-contrast chest CT and 18F-FDG-PET/CT, cardiac MRI for heart cohort) to detect fibrosis.
Timeframe: Initial scan, Baseline, 8-12 months
Trial details
NCT IDNCT07613099
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of FAPI-PET/CT or the FDG PET/CT scan.
Exclusion criteria
. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FAPI-74 or other agents used in the study.
. Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements
. Pregnancy or lactation
. Women able to become pregnant or men actively trying to father a child and are unwilling to use an effective form of birth control during the study and 4 weeks after the last 18F-FAPI-74 PET/CT scan or the FDG PET/CT scan.
. Subjects with severe claustrophobia unresponsive to oral anxiolytics.
. Subjects weighing \> 350 lbs (weight limit for PET scanner table), or unable to fit within the imaging gantry