NCT07549841RecruitingPhase 2
Exploratory Study Evaluating the Relevance of [68Ga]Ga-FAPI-46 for Staging and Identifying Progressing Patients With Transthyretin Cardiac Amyloidosis
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 1 Apr 2026
- Start date
- 9 Sept 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Nantes University Hospital
- Diseases
- Amyloidosis
- NCT number
- NCT07549841
- EU CT number
- 2025-523616-36-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 9 Sept 2026 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior participation in a clinical trial evaluating a TTR-targeted gene-silencing therapy (TTR= transthyretin) or an amyloid-depleting treatment for cardiac transthyretin amyloidosis (ATTR-CM).
Other illness
- History of Myocardial infarction or myocarditis
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Known hypersensitivity to gallium-68, to any excipient or derivative
Lab values
- Women who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study and within 48 hours prior to PET for all female subjects of childbearing potential.
Other
- Severe aortic stenosis
- Patient under guardianship or trusteeship.
- Patient under judicial protection.
- Patient unable to understand spoken or written French
Who the study is looking for
- Men or women ≥ 18 years
- Definite ATTR-CM diagnosis based on the 2021 ESC expert consensus
- Written and signed informed consent (obtained on the screening day at the latest and before any investigation)
- Affiliation with French social security system or beneficiary from such system
- Women must meet one of the following criteria at the time of inclusion:
- present a negative pregnancy test (blood test) before the injection of \[68Ga\]Ga-FAPI-46 and use highly1 effective contraceptive measures for a duration of 6 months after the PET with \[68Ga\]Ga-FAPI-46;
- or be post-menopausal (aged over 50 with amenorrhea for at least 12 months after stopping all exogenous hormone treatments);
- or (if under 50 years of age) have been in amenorrhea for at least 12 months after stopping exogenous hormone treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels corresponding to post-menopausal levels;
- or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented);
- Male patients will be required to use male contraception (condoms) for a duration of 3 months after the PET;
- Women partners will be required to use an acceptable2 contraceptive measure (as they will not receive the trial drug) for a duration of 3 months after the PET;
- Male partners will be required to use male contraception (condoms) for a duration of 6 months after the PET.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire De Nantes Coordinator of this site? Confirm its status | Nantes Cedex 1 | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.