2025-523616-36-00招募中2 期
Exploratory study evaluating the relevance of [68Ga]Ga-FAPI-46 for staging and identifying progressing patients with transthyretin cardiac amyloidosis
Centre Hospitalier Universitaire De Nantes2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comparison of quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake (SUV 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).
研究概览
简要总结
To characterize the contribution of [68Ga]Ga-FAPI-46 PET imaging in evaluating the severity of transthyretin amyloid cardiomyopathy (ATTR-CM)
研究设计
- 分配方式
- Non Randomized
- 主要目的
- Overall Trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
FAPI-46 (68Ga)
Test
干预措施: FAPI-46 (68Ga) (Drug)
结局指标
主要结局
Comparison of quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake (SUV 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).
Comparison of quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake (SUV 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).
次要结局
- 4c) Assess the potential of [68Ga]Ga-FAPI-46 to identify progressing ATTR-CM patients through comparison of automated analysis of [68Ga]Ga-FAPI-46 cardiac PET combined or not with CMR among patients with and patients without criteria for disease progression according to the 2021 and/or 2026 ESC experts consensus criteria, and patients with and without ODI
- Comparison of qualitative and quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake among patients with WT-ATTR CM and h-ATTR CM
- Tolerance of [68Ga]Ga-FAPI-46 cardiac PET will be assessed by clinical monitoring of the patient from the time of injection until approximately 60 or 90 minutes post-injection, depending on whether CT or MR imaging is performed. Clinical data will be collected prior and 5/10 min after [68Ga]Ga-FAPI-46 injection, prior to image acquisition and at the end of acquisition
- Comparison of the qualitative (absence of uptake, focal uptake, diffuse uptake, focal or diffuse uptake on both left and right ventricule) and quantitative (left ventricular and right ventricular SUVmax, SUVmean and LV molecular volume) analysis of [68Ga]Ga-FAPI-46 cardiac PET imaging to both CMR and echocardiography parameters (extent of LV late gadolinium enhancement, extracellular volume, LV and RV longitudinal strain, LV myocardial mass, LV and RV ejection fractions)
- 3a) Assess potential of [68Ga]Ga-FAPI-46 in staging ATTR-CM severity through comparison of qualitative and quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake among the Columbia stages (1-3 points ; 4-6 points ; 7-9 points) and each of its components : i. NAC and Mayo ATTR-CM stages (stage I, stage II, stage III). ii. bio-clinical parameters (NT pro BNP, eGFR and Troponin T values, daily dose of furosemide or equivalent, and NYHA functional class)
- 3b) Assess potential of [68Ga]Ga-FAPI-46 in staging ATTR-CM severity through comparison of the combined qualitative and quantitative analysis of CMR and [68Ga]Ga-FAPI-46 cardiac PET imaging to Columbia stages (1-3 points ; 4-6 points ; 7-9 points) and each of its components
- 3c) Assess potential of [68Ga]Ga-FAPI-46 in staging ATTR-CM severity through comparison of automated analysis of [68Ga]Ga-FAPI-46 cardiac PET combined or not with CMR to Columbia stages (1-3 points ; 4-6 points ; 7-9 points) and each of its components
- 4a) Assess the potential of [68Ga]Ga-FAPI-46 to identify progressing ATTR-CM patients through comparison of qualitative and quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake among patients with and patients without criteria for disease progression according to the 2021 and/or 2026 ESC experts consensus criteria, and patients with and without Oral Diuretic Intensification (ODI)
- 4b) Assess the potential of [68Ga]Ga-FAPI-46 to identify progressing ATTR-CM patients through comparison of the combined qualitative and quantitative analysis of CMR and [68Ga]Ga-FAPI-46 cardiac PET imaging among patients with and patients without criteria for disease progression according to the 2021 and/or 2026 ESC experts consensus criteria, and patients with and without ODI
- Comparison of qualitative and quantitative evaluation of [68Ga]Ga-FAPI-46 cardiac uptake to Perugini score
研究者
Thomas EUGENE
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (2)
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