ClinicalTrials.gov record NCT07549841

Exploratory Study Evaluating the Relevance of [68Ga]Ga-FAPI-46 for Staging and Identifying Progressing Patients With Transthyretin Cardiac Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Exploratory Study Evaluating the Relevance of [68Ga]Ga-FAPI-46 for Staging and Identifying Progressing Patients With Transthyretin Cardiac Amyloidosis

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2 diagnostic study tests the PET tracer [68Ga]Ga-FAPI-46 in adults with transthyretin cardiac amyloidosis. Participants receive a single [68Ga]Ga-FAPI-46 PET scan (about 40 minutes after injection), which may be paired with MRI or CT at the investigator's discretion. The study will compare tracer uptake across disease stages to evaluate its use for staging and identifying patients with progression.

What it is studying. The study tests whether heart uptake of [68Ga]Ga-FAPI-46 on PET relates to disease severity and to ongoing progression in transthyretin cardiac amyloidosis.

What the researchers hope to learn. To measure and compare [68Ga]Ga-FAPI-46 uptake in the heart across Columbia ATTR-CM stages (using left ventricular myocardial SUV to blood pool SUV). To evaluate whether this PET measure can help stage disease and identify patients with progression while on therapy.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • [68Ga]Ga-FAPI-46

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants sign informed consent and undergo a single [68Ga]Ga‑FAPI‑46 PET scan: the tracer is injected, imaging begins at about 40 minutes after injection and lasts ~20–45 minutes. The PET will be performed with either MRI or CT as chosen by the investigator. Women of childbearing potential will have a blood pregnancy test (at study start and within 48 hours before PET) and must follow the study's contraception requirements; male participants and partners must follow specified condom/contraception periods after the PET. Eligibility checks and questions about ability to comply are part of screening.

How the study is structured. Interventional, single-group Phase 2 diagnostic study without masking. Each participant receives one injection of [68Ga]Ga-FAPI-46 followed by PET imaging (acquisition about 40 minutes after injection, lasting ~20–45 minutes). Imaging is performed with either MRI or CT at the investigator's choice. The main measurement compares quantitative tracer uptake between predefined disease-stage groups.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 9, 2026
Primary completion
October 2027 (estimated)
Study completion
October 2027 (estimated)
Target enrollment
40 participants (estimated)
Last updated on registry
Sep 14, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Nantes University Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Positron emission tomography
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
biomarker
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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