2024-517971-19-01招募中2 期
Prospective, monocentric, exploratory phase II study for the evaluation of the diagnostic use of the tracer PET (18F) -Flutemetamol (Vizamyl®) in patients with cardiac amyloidosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Quantification by PET parameters of myocardial uptake of the tracer in patients with cardiac amyloidosis ATTRwt, ATTRv and AL.
研究概览
简要总结
Establish the affinity of the tracer [18F] -Flutemetamol for cardiac amyloid deposits in patients with cardiac amyloidosis ATTRwt, ATTRv and AL.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients with cardiac amyloidosis: male and female, age greater or equal 18 years diagnosed with cardiac amyloidosis. In accordance with the recommendations of the European Society of Cardiology, all of the following conditions must be present: - clinical suspicion of disease based on one or more of the following exams: cardiac examination, biomarker assay (NT-proBNP, HS-TnT, plasma protein electrophoresis, serum and urinary immunofixation, free light chains), baseline EKG, baseline echocardiography, cardiac magnetic resonance; - clearly positive osteophilic radiopharmaceutical scintigraphy (Perugini 2-3) in the absence of serum and/or urinary monoclonal component OR abdominal fat biopsy and/or endomyocardial biopsy showing ATTR or AL amyloidosis; - genetic characterization to identify patients with ATTRv; - ability to provide consent to the study.
- •Control subjects: male and female, age greater or equal 18 years diagnosed with not-infiltrative left ventricular hypertrophy;
- •ability to consent to the study.
排除标准
- •pregnancy confirmed by plasma beta-HCG on women with childbearing potential and sexually active not employing highly effective contraceptive methods with a low dependency on the user (from the screening to the end of visit 1), which include: i. abstinence, ii. sexual intercourse only with same-sex partners, iii. monogamous relationship with a partner with prior vasectomy, iv. intrauterine device, v. combined hormonal contraception including estrogens and progesteron-like hormones plus the inhibition of ovulation (oral, intravaginal or transdermal), vi. hormonal contraception based on progesterone-like compounds plus the inhibition of ovulation (oral, injectable, implantable), viii. intrauterine device with hormone release. The highly effective contraceptive measures above are not required for women made sterile by surgical means (for example through tube ligation, hysterectomy, bilateral salpingectomy, bilateral ovariectomy) or after the menopause, defined as 12 months of spontaneous amenorrhea without another clinical cause and with elevated FSH levels in agreement with the expected values for the menopause. For patients with true abstinence or with just samesex partners, contraception is not required, as far as this is in line with their preferred and habitual lifestyle. Periodical abstinence (for example, estimate of the timing of ovulation or assessment of body temperature) and coitus interruptus are not acceptable contraceptive methods. If a patient stops to be abstinent, she must use the highly effective contraceptive methods above. The pregnancy status in women potentially fertile will be checked at baseline through the measurement of beta human gonadotropin on the serum;
- •breastfeeding;
- •known ischemic heart disease;
- •hypersensitivity to the active substance or to any of the excipients listed in the chapter 6.1 of the simplified IMPD;
- •severe hepatic insufficiency [alteration in the presence of known chronic liver disease of AST (male normal range> 34 IU / L; female <30 IU / L), ALT (male normal range 10-40 IU / L; female 7-35 IU / L), gamma-GT (normal range 7-64 IU / L), albumin (normal range 3.5-5 g / dl), prothrombin activity (normal range PT 70-120%) and bilirubin (normal range> 1,2 mg/dl)];
- •severe renal insufficiency [GFR estimated from creatinine and BUN <30 mL/ min/1.73 m2]; PET/CT or scintigraphic examination 24 hours prior to enrolment;
- •participation in a clinical study with an investigational drug administered within 30 days before the screening or 5 half-lives of the study drug, whichever the longest
结局指标
主要结局
Quantification by PET parameters of myocardial uptake of the tracer in patients with cardiac amyloidosis ATTRwt, ATTRv and AL.
Quantification by PET parameters of myocardial uptake of the tracer in patients with cardiac amyloidosis ATTRwt, ATTRv and AL.
次要结局
- Quantification of myocardial uptake of the tracer in patients with ATTRv, in patients with ATTRwt, in patients with AL and in control subjects
- Quantitative differentiation of myocardial tracer uptake in patients with different ATTRv genotypes
- Quantification of myocardial uptake of the tracer in patients with ATTR and weakly positive or negative scintigraphy (Perugini 0–1)
- Identification and quantification of any areas of systemic uptake of the radiopharmaceutical referred to the presence of amyloid deposits (systemic amyloidosis)
研究者
Stefania Biagini
Scientific
Fondazione Toscana Gabriele Monasterio
研究点 (1)
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