FAPI PET Imaging to See Fibroblast Activity in Nonischemic Cardiomyopathy
Official title: Mapping Myocardial Fibroblast Activation With FAPI PET Imaging in Nonischemic Cardiomyopathy
Run by Peking Union Medical College Hospital · NCT07878338 · Data updated 2026-11-12
This study tests whether a special PET/CT scan using 18F-AlF-NOTA-FAPI-04 can reveal active fibroblast activity in the hearts of adults with nonischemic cardiomyopathy to help understand disease behavior and guide care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | December 2, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07878338 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–90 with a confirmed nonischemic cardiomyopathy who can consent and do not have significant coronary artery disease or contraindications to PET imaging.
✕Probably not a fit
Patients with nonischemic cardiomyopathy who have little to no active fibroblast remodeling or who meet exclusion criteria may not see a benefit from this imaging approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial investigates the noninvasive 18F-AlF-NOTA-FAPI-04 PET/CT imaging modality in patients with nonischemic cardiomyopathy. It aims to determine whether PET signals reflecting activated cardiac fibroblasts add value to phenotyping, tracking treatment response, and stratifying prognosis beyond standard imaging. Participants will receive the radiotracer and undergo PET/CT imaging; findings will be correlated with clinical and imaging data. The study addresses the role of fibroblast activation in adverse remodeling and seeks to clarify how FAPI uptake relates to established myocardial abnormalities. Eligibility includes adults aged 18–90 with confirmed nonischemic cardiomyopathy, without significant coronary disease, pregnancy, or contraindications to imaging.
Why it matters
Potential benefit: If successful, the imaging approach could improve risk stratification and help tailor therapies by identifying ongoing fibroblast-driven remodeling.
How similar studies have gone: Previous work suggests that FAPI-based imaging can visualize active fibroblast activity in heart disease, supporting potential utility, though results are still evolving.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. males or females: age 18-90 years 2. with a confirmed diagnosis of nonischemic cardiomyopathy by standard criteria 3. must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements Exclusion Criteria: 1. coronary atherosclerotic disease (CAD) according to electrocardiogram, coronary artery CTA, or coronary angiography 2. pregnancy or breastfeeding 3. severe claustrophobia 4. inability or refusal of consent 5. any condition deemed by the investigator to interfere with study results or increase participant risk
Where it's running
-
Peking Union Medical College Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Li Huo
- Email: huoli@pumch.cn
- Phone: +86 18612672038
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.