New scan could spot hidden scarring in heart and lungs before It's too late
NCT ID NCT07613099
First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 59 times
Summary
This study tests a new radioactive tracer called 18F-FAPI-74 that may help detect scar tissue (fibrosis) in the heart and lungs earlier than current methods. Researchers will compare this new PET/CT scan to standard imaging in 210 adults with conditions like lung disease or heart problems. The goal is to see if the tracer can identify active scarring, which could lead to earlier treatment and better monitoring of disease progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-FAPI-74 (a radioactive tracer for PET/CT scans)
- What this could lead to
- If successful, this could lead to a better way to detect scarring early in heart and lung diseases, allowing doctors to start treatment sooner and track disease progression more accurately.
- What could go wrong
- This is an early-stage imaging study, not a treatment. The tracer may not prove more effective than current scans, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2033
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Participant \>=18 years old 4. Has a specific diagnosis of a cardiopulmonary and/or vascular disease that puts them at risk of developing or having developed tissue fibrosis. 5. Has undergone prior imaging of lungs, heart, and/or vasculature with chest CT 6. Able to lie on the PET/CT scanner for imaging up to 45 minutes. 7. 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. 8. 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. 9. Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: 1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FAPI-74 or other agents used in the study. 2. Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements 3. Pregnancy or lactation 4. 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. 5. Subjects with severe claustrophobia unresponsive to oral anxiolytics. 6. Subjects weighing \> 350 lbs (weight limit for PET scanner table), or unable to fit within the imaging gantry
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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