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NCT07613099 · ClinicalTrials.gov registry record · Phase 3
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
A Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Not yet
- Registry status
- Phase 3
- Development phase
- 210
- Enrollment target
NCT07613099: Clinical Trial Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT07613099 is a Phase 3 study that has not yet begun recruiting, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 210 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07613099, a Phase 3 study, has not yet begun recruiting, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 210 participants
- Enrollment target
Study 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....
Primary Outcome
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.
Interventions
- DRUG [18F]FAPI-74
- DIAGNOSTIC_TEST 18F-FAPI-74 PET/CT Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2033-05-26 |
| Phase | Phase 3 |
What is known before NCT07613099 opens enrollment
NCT07613099 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which [18F]FAPI-74 is the first listed.
NCT07613099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07613099 about?
NCT07613099 is a clinical study titled "Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging". 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 b...
What is the current status of trial NCT07613099?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2026-07-15. Estimated completion is 2033-05-26.
What interventions are being tested in trial NCT07613099?
The interventions under investigation include: [18F]FAPI-74 (DRUG), 18F-FAPI-74 PET/CT Imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07613099?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07613099's enrollment target sits among peer trials
210 1338th of 2000 higher than 656 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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