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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT07613099
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Acute Lung Injury
  • Allogeneic Stem Cell Transplantation
  • Cardiovascular Diseases
  • Interstitial Lung Disease
  • Lung Allograft Transplantation
  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • [18F]FAPI-74 — DRUG
    Participants will undergo baseline diagnostic 18F-FAPI-74 PET/CT in addition to standard of care imaging (non-contrast chest CT and 18FFDG- PET/CT, cardiac MRI for heart cohort). A follow-up 18F-FAPI- 74 PET/CT with SOC imaging will be performed at 8 to 12 months after the initial scan to assess progression and or the effects of therapies.
  • 18F-FAPI-74 PET/CT Imaging — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
May 2026
Primary completion
May 26, 2031
Completion
May 26, 2033

Study Design

Enrollment
210 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: Acute lung injury
    Acute lung injury undergoing FAPI/PET/CT
  • Other: Allogeneic stem cell transplantation
    Allogeneic stem cell transplantation undergoing FAPI/PET/CT
  • Other: Cardiovascular diseases
    Cardiovascular diseases undergoing FAPI/PET/CT
  • Other: Interstitial lung disease
    Interstitial lung disease undergoing FAPI/PET/CT
  • Other: Lung allograft transplantation
    Lung allograft transplantation undergoing FAPI/PET/CT
  • Other: Pulmonary arterial hypertension
    Pulmonary arterial hypertension undergoing FAPI/PET/CT

Primary Outcome Measure

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. [ Time Frame: Initial scan, Baseline, 8-12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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