Exploratory Study Evaluating the Relevance of [68Ga]Ga-FAPI-46 for Staging and Identifying Progressing Patients With Transthyretin Cardiac Amyloidosis
Condition(s) studied
Investigational drug(s) / intervention(s)
[68Ga]Ga-FAPI-46: \[68Ga\]Ga-FAPI-46 PET acquisition at approximatively 40 min after the injection over 20-45 minutes. The PET imaging will be associated with either MRI or CT at the investigator's discretion.
Study summary
Transthyretin cardiac amyloidosis (ATTR-CM) is an infiltrative cardiomyopathy caused by amyloid fibril deposition, leading to heart failure and arrhythmias. Despite advances in diagnosis, the disease remains commonly unrecognized and presents heterogeneously. Recent therapies targeting transthyretin stabilization and gene silencing have improved outcomes, but current staging systems based on biological and functional markers have limited ability to guide treatment.
Imaging techniques such as cardiac magnetic resonance (CMR) provide tissue characterization, but noninvasive molecular imaging of myocardial fibrotic activity remains limited. Positron emission tomography (PET) tracers targeting fibroblast activation protein (FAPI), labeled with gallium-68 (68Ga), offer a promising approach to detect and quantify fibroblast activity associated with myocardial remodeling.
This study aims to evaluate \[68Ga\]Ga-FAPI PET imaging for staging ATTR-CM and distinguishing patients with disease progression under therapy. The investigators hypothesize that \[68Ga\]Ga-FAPI uptake reflects fibrotic activity correlating with disease severity and progression. If validated, \[68Ga\]Ga-FAPI PET could serve as a novel biomarker for improved staging and personalized strategies in ATTR-CM.
Eligibility
Primary outcome measure(s)
- Comparison of quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake — within 30 days
Comparison of quantitative evaluation of \[68Ga\]Ga-FAPI-46 cardiac uptake (SUV (Standard Uptake Value) Ratio : left ventricular myocardial SUV to blood pool SUV) among the different Columbia ATTR-CM stages (1-3 points ; 4-6 points ; 7-9 points) in order to characterize the contribution of \[68Ga\]Ga-FAPI-46 PET imaging in evaluating the severity of transthyretin amyloid cardiomyopathy (ATTR-CM).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Chu Nantes | Nantes | France | Recruiting |
More Nantes University Hospital trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07549841 on ClinicalTrials.gov ↗ ← All trials in France