Transthyretin Cardiac AmyloidosisPhase 2FAPICAMNCT07549841
Exploratory Study Evaluating the Relevance of [68Ga]Ga-FAPI-46 for Staging and Identifying Progressing Patients With Transthyretin Cardiac Amyloidosis
A Phase 2 study testing [68Ga]Ga-FAPI-46 in people with Transthyretin Cardiac Amyloidosis, run by Nantes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthyretin Cardiac Amyloidosis
- What is being tested?
- [68Ga]Ga-FAPI-46
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2026to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- Patient under judicial protection.
- Patient unable to understand spoken or written French
- Known hypersensitivity to gallium-68, to any excipient or derivative
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nicolas PIRIOU, MD contact
France1 site, 1 recruiting
- Recruiting
Chu Nantes
Nantes, 44093
Faustine LELAN, PhD, 0276643491 ext. +33, faustine.lelan@chu-nantes.fr
Nicolas PIRIOU, MD
About this study
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.
- Conditions
- Transthyretin Cardiac Amyloidosis
- Being tested
- [68Ga]Ga-FAPI-46
- Keywords
- FAPI-46, staging and identifying progressing patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-FAPI-46Drug
[68Ga]Ga-FAPI-46 PET acquisition at approximatively 40 min after the injection over 20-45 minutes. The PET imaging will be associated with either MRI or CT at the investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-FAPI-46 PET | Other | [68Ga]Ga-FAPI-46 PET acquisition at approximatively 40 min after the injection over 20-45 minutes. The PET imaging will be associated with either MRI (magnetic resonance imaging) or CT (computed tomography) at the investigator's discretion. Receives: Drug: [68Ga]Ga-FAPI-46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake
Comparison of quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake (SUV (Standard Uptake Value) Ratio : left ventricular myocardial SUV to blood pool SUV) among the different Columbia ATTR-CM stages (1-3 points ; 4-6 points ; 7-9 points) in order to characterize the contribution of [68Ga]Ga-FAPI-46 PET imaging in evaluating the severity of transthyretin amyloid cardiomyopathy (ATTR-CM).
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start9 Sep 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Cardiac AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 40 patients divided into 3 groups based on the Columbia staging system: group A (low risk:1-3 points), group B (intermediate risk: 4-6) and group C (high risk patients :7-9). Each group will enroll in parallel and consist of both treatment-naïve patients and patients already undergoing treatment, including some who have been treated for over a year.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549841
- Sponsor's protocol ID
- RC25_0276
- Other IDs
- 2025-523616-36-00, 2025
- Acronym
- FAPICAM
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Evaluating the Relevance of [68Ga]Ga-FAPI-46 for Staging and Identifying Progressing Patients With Transthyretin Cardiac Amyloidosis
- ClinicalTrials.gov ID
- NCT07549841
- Acronym / sponsor ID
- FAPICAM / RC25_0276
- Conditions
- Transthyretin Cardiac Amyloidosis
- Keywords
- FAPI-46, staging and identifying progressing patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 40 patients divided into 3 groups based on the Columbia staging system: group A (low risk:1-3 points), group B (intermediate risk: 4-6) and group C (high risk patients :7-9). Each group will enroll in parallel and consist of both treatment-naïve patients and patients already undergoing treatment, including some who have been treated for over a year.
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-FAPI-46 PET | Other | Drug: [68Ga]Ga-FAPI-46[68Ga]Ga-FAPI-46 PET acquisition at approximatively 40 min after the injection over 20-45 minutes. The PET imaging will be associated with either MRI (magnetic resonance imaging) or CT (computed tomography) at the investigator's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-FAPI-46[68Ga]Ga-FAPI-46 PET acquisition at approximatively 40 min after the injection over 20-45 minutes. The PET imaging will be associated with either MRI or CT at the investigator's discretion. | Drug | [68Ga]Ga-FAPI-46 PET |
Primary outcome
Comparison of quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake
Time frame: within 30 days
Comparison of quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake (SUV (Standard Uptake Value) Ratio : left ventricular myocardial SUV to blood pool SUV) among the different Columbia ATTR-CM stages (1-3 points ; 4-6 points ; 7-9 points) in order to characterize the contribution of [68Ga]Ga-FAPI-46 PET imaging in evaluating the severity of transthyretin amyloid cardiomyopathy (ATTR-CM).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
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PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels
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Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
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A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas PIRIOU, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [68Ga]Ga-FAPI-46 in people with Transthyretin Cardiac Amyloidosis, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas EUGENE, MD (02 40 08 41 36 ext. +33, Thomas.EUGENE@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake (time frame: within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.