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Evaluation of [68Ga]Ga-FAPI-46 PET Imaging for Staging and Detecting Disease Progression in Patients with Transthyretin Cardiac Amyloidosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on transthyretin cardiac amyloidosis, a condition where a misfolded protein called transthyretin builds up in the heart muscle and can make the heart work less efficiently. To look at the disease, participants will receive an injection of a special imaging substance called FAPI-46 (68Ga). This substance helps doctors see how much of the protein is affecting the heart when a scan is performed.

The purpose of the study is to find out whether this imaging test can accurately show how severe the heart involvement is. After the injection, a short‑lasting scan using PET technology will be done, which creates pictures of the heart by detecting the injected substance. Depending on the equipment available, the scan may be combined with either a CT scan (a type of X‑ray picture) or an MRI scan (a magnetic scan that shows detailed pictures of the heart).

Participants will be monitored for any immediate reactions right after the injection and then again a few minutes later. The imaging session lasts about one hour, during which the heart is photographed from different angles. All information gathered will be used only to understand how well the new imaging method works for this disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline clinical monitoring

    Upon joining the study, you will undergo a brief health check that records vital signs and any symptoms before any medication is given.

    This information serves as a reference for later comparisons.

  2. Step 2

    Intravenous injection of <b>fapi-46 (68ga)</b>

    A single dose of 200 mbq of the tracer is injected into a vein using a sterile needle.

    The injection is performed by trained staff and takes only a few seconds.

  3. Step 3

    Early post‑injection monitoring

    Clinical data are collected again at either 5 minutes or 10 minutes after the injection, depending on the imaging protocol.

    The same vital signs and symptom checks are repeated to assess immediate tolerance.

  4. Step 4

    Pet imaging acquisition

    After the early monitoring, you will be positioned on a scanner for pet imaging combined with either ct or mr.

    The scan starts shortly after injection and continues until approximately 60 minutes post‑injection if a ct is used, or up to about 90 minutes if an mr is used.

  5. Step 5

    Final clinical assessment

    When the imaging session ends, a final set of vital signs and symptom questions are recorded.

    This completes the data collection required for the study visit.

Who can join the trial?

11 criteria

  • Be at least 18 years old and identify as male or female.
  • Have a confirmed diagnosis of transthyretin cardiac amyloidosis (ATTR‑CM) according to the 2021 guidelines from the European Society of Cardiology (ESC).
  • Provide a written and signed consent form on the screening day or earlier, before any study procedures are done.
  • Be covered by the French social security system or be a beneficiary of that system.
  • If you are a woman, you must meet one of the following conditions at the time of joining the study:
    • Show a negative pregnancy test (blood test) before the imaging injection and use a highly effective birth‑control method for 6 months after the scan.
    • Be post‑menopausal, meaning you are over 50 years old and have not had a period for at least 12 months after stopping any hormone treatments.
    • If under 50 years old, have not had a period for at least 12 months after stopping hormone treatments and have blood levels of luteinizing hormone (LH) and follicle‑stimulating hormone (FSH) that match post‑menopausal levels.
    • Have had permanent surgical sterilization (such as a hysterectomy, removal of both ovaries, or removal of both fallopian tubes) with proper documentation.
    • Male participants must use condoms (or another reliable male birth‑control method) for 3 months after the imaging scan.
    • If you have a female partner who is not taking part in the study, she must use an acceptable birth‑control method for 3 months after the scan.
    • If you have a male partner who is not taking part in the study, he must use condoms (or another reliable male birth‑control method) for 6 months after the scan.

Who cannot join the trial?

8 criteria

  • History of heart attack (medical term: myocardial infarction) or heart muscle inflammation (myocarditis).
  • Having severe aortic stenosis, which means the main heart valve is very narrowed.
  • Any condition—psychological, family, social, or living‑area—that could make it difficult to follow the study plan or attend follow‑up visits.
  • Women who are pregnant (carrying a developing baby) or breastfeeding (feeding a baby with breast milk); a pregnancy test will be required before the scan.
  • Being under legal guardianship or trusteeship, where another person makes medical decisions for you.
  • Being under judicial protection, a court‑ordered status that limits personal decision‑making.
  • Inability to understand spoken or written French.
  • Current or past participation in another clinical trial testing a gene‑silencing therapy or an amyloid‑depleting treatment for this heart condition.
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Investigated drugs

FAPI-46 (68Ga) is a special radioactive medicine that is given through an IV. It travels in the bloodstream and attaches to a protein that is often found in damaged heart tissue. After it is injected, a PET scanner can see the tiny amount of radiation and make pictures that show where the medicine has gathered. In this trial, those pictures help doctors understand how much amyloid protein has built up in the heart of people with transthyretin cardiac amyloidosis and whether the disease is getting worse. The medicine does not treat the condition; it only provides detailed images to guide further care.

What is already known about the treatment

FAPI-46 (68Ga) - It is given as an intravenous injection of about 200 MBq and is used as a PET imaging tracer. The agent is still in the research stage and is not yet approved for routine clinical use, though it is being studied in several trials. It helps doctors see areas of heart tissue where a protein called fibroblast activation protein is active, which is common in transthyretin cardiac amyloidosis. FAPI‑46 (68Ga) belongs to the class of radiopharmaceuticals that target fibroblast activation protein for diagnostic imaging.

Investigated diseases

  • Transthyretin cardiac amyloidosis

    A condition where abnormal transthyretin protein builds up in the heart tissue, making the walls stiff. The buildup gradually reduces the heart’s ability to relax and fill with blood. Over time the heart may work harder to pump, leading to changes in its size and function. The disease can advance through stages that reflect increasing protein accumulation and heart strain.

  • Wild-type transthyretin amyloid cardiomyopathy

    A form of transthyretin cardiac amyloidosis that occurs without a genetic mutation, usually appearing later in life. Protein deposits slowly increase in the heart, causing the walls to thicken and become less flexible. As the deposits grow, the heart’s pumping efficiency can decline. The progression is measured by the amount of protein and related changes in heart performance.

  • Hereditary transthyretin amyloid cardiomyopathy

    This type is caused by inherited mutations in the transthyretin gene, leading to earlier and sometimes faster protein buildup in the heart. The abnormal protein accumulates, making the heart muscle stiff and thickened. With increasing deposits, the heart’s ability to fill and contract can worsen. The disease advances as more protein is deposited and heart function changes.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523616-36-00Protocol codeRC25_0276Estimated enrolment40 patientsSponsorCentre Hospitalier Universitaire De Nantes

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