Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- standardized uptake value (SUV) measures
研究概览
简要总结
To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.
详细描述
Hypothesis had been performed that PET with 18F-Flutemetamol (Vizamyl®) could lead an early diagnostic. Indeed, this tracer had been recently used to highlight inter-cerebral beta-amyloid plaques on patients with Alzheimer Disease.
Because this labelling is performed on amyloid deposits, this tracer would lead to view and to quantify amyloid deposits within cardiac amyloid injuries.
Results of this PET will be combined with scan examinations for a better anatomic tracking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients followed for amyloidosis with proved cardiac injury or strongly suspected:
- •cardiac echography with typical signs of amyloid injury,
- •anatomical result confirming presence of amyloid deposits at cardiac or peripheral level
- •Signature of Informed Consent Form,
- •Affiliation to a social security system
排除标准
- •Patient who suffers from another pathology which could lead cardiac injury (coronary disease, valvular disease, other pathology of deposit),
- •Pregnancy and lactating women,
- •Absence of effective contraception,
- •Irradiating examination performed within the last 12 months or scheduled within the next 12 months,
- •Unable patient physically, mentally or legally to provide informed consent,
- •Patient under a system of legal protection
研究组 & 干预措施
PET with 18 F-Flutemetamol
PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication
干预措施: PET with 18 F-Flutemetamol (Drug)
结局指标
主要结局
standardized uptake value (SUV) measures
时间窗: average of last 15 minutes
standardized uptake value (SUV) measures
ratio Heart/ Upper Mediastinum
时间窗: average of last 15 minutes
peak of 18F-Flutemetamol capture
次要结局
未报告次要终点