Study 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 study about?

The study focuses on patients with Transthyretin cardiac amyloidosis, a condition where abnormal protein builds up in the heart and makes it less able to pump blood. The investigation uses a special imaging agent called FAPI-46 (68Ga), which is given as an injection into a vein to help a scanner see how much of the protein is present in the heart muscle.

The main purpose is to find out how well a PET scan with this agent can show the severity of the disease. After a brief health check, participants receive the injection and then undergo imaging with either a CT or MRI scanner. The scan takes about an hour, followed by a short observation period and a few follow‑up checks to record any reactions.

The results are compared with standard heart tests such as echocardiography and other measurements to see if the new scan can better identify patients whose condition is getting worse. All procedures are non‑surgical and last only a few hours in total.

1 enrollment and initial visit

after joining the study, you will attend an initial visit where the purpose of the study is explained and written consent is obtained.

clinical staff will record your medical history, current medications, and perform basic measurements such as blood pressure and heart rate.

2 baseline clinical assessment

before any medication is given, a baseline clinical assessment is performed.

this includes checking vital signs, collecting a short blood sample if required, and noting any symptoms you may have at that moment.

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

you will receive a single intravenous injection of fapi-46 at a dose of 200 mbq (megabecquerels).

the injection is given through a small needle placed in a vein in your arm.

intravenous means the medication goes directly into your bloodstream.

4 immediate post‑injection monitoring

clinical staff will monitor you continuously from the moment of injection until about 60 or 90 minutes later, depending on the type of imaging performed.

specific checks are recorded prior to the injection, at approximately 5 minutes and 10 minutes after the injection, just before the imaging starts, and at the end of the imaging session.

5 pet imaging acquisition (with ct or mr)

a positron emission tomography (pet) scan is performed to visualize the distribution of fapi-46 in your heart.

the scan may be combined with either a computed tomography (ct) scan or a magnetic resonance (mr) scan to provide detailed anatomical information.

the imaging period lasts until approximately 60 minutes after injection if a ct scan is used, or up to 90 minutes if an mr scan is used.

6 final clinical check and data collection

after the imaging is completed, staff will perform a final check of your vital signs and ask about any sensations experienced during the procedure.

all clinical data and imaging results are recorded for later analysis.

7 study completion

once the final check is finished, your participation in this particular study visit is complete.

no further study‑specific procedures are required unless a separate follow‑up visit is scheduled by the study team.

Who Can Join the Study?

Be 18 years old or older.
Have a confirmed diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) based on the 2021 European Society of Cardiology expert guidelines (this means doctors have verified the specific heart disease using accepted criteria).
Provide a written and signed consent form on the screening day before any study procedures are performed.
Be covered by the French social security system or receive benefits from it.
If you are a woman, meet one of the following conditions at the time of enrollment:
- Show a negative pregnancy test (blood test) before the injection and use a highly effective birth‑control method for 6 months after the PET scan.
- Be post‑menopausal, defined as being over 50 years old and having no menstrual periods for at least 12 months after stopping any hormone medicines.
- If under 50, have had no periods for at least 12 months after stopping hormone medicines and have blood levels of luteinizing hormone (LH) and follicle‑stimulating hormone (FSH) that match those of a post‑menopausal woman.
- Have had permanent surgical sterilization (removal of the uterus, both ovaries, or both fallopian tubes) with proper documentation.
Male participants must use condoms (or another reliable male contraception) for 3 months after the PET scan.
The female partner of a male participant must use an acceptable form of birth control for 3 months after the PET scan.
The male partner of a female participant must use condoms for 6 months after the PET scan.

Who Cannot Join the Study?

History of heart attack (medical term: myocardial infarction) or heart muscle inflammation (myocarditis)
Severe narrowing of the aortic valve (medical term: severe aortic stenosis)
Any psychological, family, social, or location‑related condition that could make it difficult to follow the study plan or attend follow‑up visits
Being pregnant or breastfeeding (a pregnancy test will be done for women who could become pregnant)
Being under a legal guardian or trustee who makes decisions for you
Being under court‑ordered protection (judicial protection)
Inability to understand spoken or written French
Current or past participation in another trial testing a gene‑silencing or amyloid‑removing treatment for this heart condition

Where you can join this trial?

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Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nantes	Nantes	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.06.2026

Trial locations

Investigated drugs:

(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-Cyano-4,4-Difluoropyrrolidin-1-Yl)-2-Oxoethylcarbamoyl)-Quinolin-6-Yl)(Methyl)Amino)-Propyl)Piperazin-1-Yl)-2-Oxoethyl)-68Ga-[1,4,7,10]-Tetraazacyclododecane-1,4,7-Triyl)Triacetate

FAPI-46 (68Ga) is a special imaging agent that contains a tiny amount of a radioactive substance. It is given by an injection into a vein and then the patient undergoes a PET scan. The tracer travels to the heart and lights up areas where a protein called fibroblast activation protein is active. By showing these areas, doctors can see how much amyloid protein has built up in the heart and whether the disease is getting worse. This helps researchers understand the severity and progression of transthyretin cardiac amyloidosis in the study.

Transthyretin cardiac amyloidosis – A condition in which abnormal transthyretin protein builds up as amyloid deposits in the heart muscle. The deposits cause the walls of the heart chambers to become stiff, limiting the heart’s ability to fill with blood. Over time, the thickened walls can lead to reduced pumping efficiency and gradual worsening of heart function.

Trial ID:

2025-523616-36-00

Protocol code:

RC25_0276

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of [68Ga]Ga-FAPI-46 PET imaging for staging and detecting disease progression in patients with transthyretin cardiac amyloidosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?