68Ga-FAPI-46 PET imaging to stage ATTR-CM and spot progression

Is this trial a fit for you?

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 study uses [68Ga]Ga-FAPI-46 PET imaging to map myocardial fibroblast activity in patients with definite ATTR-CM. The goal is to see if the imaging can improve staging and identify progressing disease beyond current markers. Participants receive a single injection of [68Ga]Ga-FAPI-46 followed by PET imaging and analysis. The study is conducted at Nantes University Hospital in France under the French social security system. Safety, feasibility, and potential diagnostic value of this imaging approach will be evaluated.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu Nantes
  Nantes, France Recruiting

Study contacts

• Study coordinator: Thomas EUGENE, MD
• Email: Thomas.EUGENE@chu-nantes.fr
• Phone: 02 40 08 41 36

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.