NCT07549841 Exploratory Study Evaluating the Relevance of [68Ga]Ga-FAPI-46 for Staging and Identifying Progressing Patients With Transthyretin Cardiac Amyloidosis
| NCT ID | NCT07549841 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nantes University Hospital |
| Condition | Transthyretin Cardiac Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-09-09 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2026-09-09 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * History of Myocardial infarction or myocarditis * Severe aortic stenosis * 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). * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * 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. * Patient under guardianship or trusteeship. * Patient under judicial protection. * Patient unable to understand spoken or written French * Known hypersensitivity to gallium-68, to any excipient or derivative
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07549841 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Transthyretin Cardiac Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07549841 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07549841 currently recruiting?
Yes, NCT07549841 is actively recruiting participants. Contact the research team at Thomas.EUGENE@chu-nantes.fr for enrollment information.
Where is the NCT07549841 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT07549841 clinical trial?
NCT07549841 is sponsored by Nantes University Hospital. The trial plans to enroll 40 participants.