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Exploratory study evaluating the relevance of [68Ga]Ga-FAPI-46 for staging and identifying progressing patients with transthyretin cardiac amyloidosis
EU CTIS ID: 2025-523616-36-00
What this study is testing
To characterize the contribution of [68Ga]Ga-FAPI-46 PET imaging in evaluating the severity of transthyretin amyloid cardiomyopathy (ATTR-CM)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men or women ≥ 18 years
- Definite ATTR-CM diagnosis based on the 2021 ESC expert consensus
- Written and signed 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 highly effective contraceptive measures for a duration of 6 months after the PET • 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;
You likely can't join if
- History of Myocardial infarction or myocarditis
- Severe aortic stenosis
- 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.
See the full eligibility criteria
- Men or women ≥ 18 years
- Definite ATTR-CM diagnosis based on the 2021 ESC expert consensus
- Written and signed 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 highly effective contraceptive measures for a duration of 6 months after the PET • 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 acceptable 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.
- History of Myocardial infarction or myocarditis
- Severe aortic stenosis
- 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
- Current or prior participation in a clinical trial evaluating a TTR-targeted gene-silencing therapy or an amyloid-depleting treatment for cardiac transthyretin amyloidosis (ATTR-CM).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.