EUCTR2017-001660-38-IT进行中（未招募）1 期
A prospective triple-arm, monocentric, phase-II explorative study on evaluation of diagnostic efficacy of the PET tracer (18F)-florbetaben (Neuraceq®) in patients with cardiac amyloidosis - FLORAMICAR 2 - FLORAMICAR 2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Group of patients with cardiac amyloidosis AL and ATTR: males or females, age>20 years, patient with diagnosis of cardiac amyloidosis.
- •Group of patients with non-infiltrative hypertrophic cardiomyopathy: males or females, age>20 years, non-infiltrative hypertrophic cardiomyopathy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients previously enrolled in FLORAMICAR study (EudraCT 2015-005384-16), pregnancy checked by plasma beta-HCG or breastfeeding, known ischemic heart disease, hypertrophic cardiomyopathy, storage diseases or other known causes of left ventricular hypertrophy or pseudohypertrophy, hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SPC) Neuraceq®, severe renal failure, liver failure, PET / CT or scintigraphic examination 24 h before enrollment.
研究者
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