Allogeneic Stem Cell TransplantationPhase 3NCT07613099
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
A Phase 3 study testing [18F]FAPI-74 and 18F-FAPI-74 PET/CT Imaging in people with Allogeneic Stem Cell Transplantation and Lung Allograft Transplantation, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Allogeneic Stem Cell Transplantation, Lung Allograft Transplantation, Interstitial Lung Disease
- What is being tested?
- [18F]FAPI-74 and 18F-FAPI-74 PET/CT Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2026to 26 May 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following 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
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- 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.
- 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.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Evaluation of 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 be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help.
Read more
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....
Read the 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. To assess the usefulness of cardiopulmonary imaging with low-field heart lung MRI for characterization of the lung microarchitecture, microvascular perfusion, regional ventilation, and late gadolinium enhancement.
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. To assess the usefulness of
cardiopulmonary imaging with low-field heart lung MRI for characterization of the lung microarchitecture, microvascular perfusion, regional ventilation, and late gadolinium enhancement.
- Conditions
- Allogeneic Stem Cell Transplantation, Lung Allograft Transplantation, Interstitial Lung Disease, Acute Lung Injury, Pulmonary Arterial Hypertension, Cardiovascular Diseases
- Being tested
- [18F]FAPI-74, 18F-FAPI-74 PET/CT Imaging
- Keywords
- Fibroblast activation protein (FAP) FAPI/PET, Fibrotic Disease Activity
- Medical subject headings
- Lung Diseases, Interstitial, Acute Lung Injury, Pulmonary Arterial Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FAPI-74Drug
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 ImagingDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Acute lung injury | Other | Acute lung injury undergoing FAPI/PET/CT Receives: Drug: [18F]FAPI-74; Diagnostic Test: 18F-FAPI-74 PET/CT Imaging |
| Allogeneic stem cell transplantation | Other | Allogeneic stem cell transplantation undergoing FAPI/PET/CT Receives: Drug: [18F]FAPI-74; Diagnostic Test: 18F-FAPI-74 PET/CT Imaging |
| Cardiovascular diseases | Other | Cardiovascular diseases undergoing FAPI/PET/CT Receives: Drug: [18F]FAPI-74; Diagnostic Test: 18F-FAPI-74 PET/CT Imaging |
| Interstitial lung disease | Other | Interstitial lung disease undergoing FAPI/PET/CT Receives: Drug: [18F]FAPI-74; Diagnostic Test: 18F-FAPI-74 PET/CT Imaging |
| Lung allograft transplantation | Other | Lung allograft transplantation undergoing FAPI/PET/CT Receives: Drug: [18F]FAPI-74; Diagnostic Test: 18F-FAPI-74 PET/CT Imaging |
| Pulmonary arterial hypertension | Other | Pulmonary arterial hypertension undergoing FAPI/PET/CT Receives: Drug: [18F]FAPI-74; Diagnostic Test: 18F-FAPI-74 PET/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Initial scan, Baseline, 8-12 months
Secondary outcomes (2)
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
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-FDG-PET/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).
Measured: Baseline, 8-12 months
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
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.
Measured: Baseline, 8-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start18 Sep 2026
- Primary completion26 May 2031 (estimated)
- Study completion26 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anthony F Suffredini, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613099
- Sponsor's protocol ID
- 10002534
- Other IDs
- 002534-H
- Status last verified
- 1 Oct 2026
- First submitted
- 28 May 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: refer to the DMSP