18F-Florbetaben (Neuraceq®) PET/MRI Evaluation of Cardiac Amyloid
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of participants with 18F-Florbetaben (Neuraceq®) uptake on Fused PET/MRI Images
研究概览
简要总结
Cardiac amyloidosis is a disorder characterized by the deposition of abnormal proteins called amyloid in the heart tissue. This makes it difficult for the heart to function properly. The investigators wish to evaluate if the radiopharmaceutical 18F-Florbetaben (Neuraceq®) that targets beta amyloid can also identify cardiac amyloid deposition.
详细描述
The use of hybrid positron emission tomography/ magnetic resonance imaging (PET/MRI) scanners in clinical practice enhance the ability to evaluate the heart from both an anatomical and functional perspective. It is hypothesized that an increased PET signal of 18F-Florbetaben (Neuraceq®) will be detected in cardiac amyloid deposits within the heart tissue, while the MRI provides the anatomical information. The ability to reliably and non-invasively image amyloid deposition in the heart would be potentially advantageous in the following scenarios:
- Diagnosis of cardiac amyloidosis
- Decreasing unnecessary invasive myocardial procedures.
The investigators believe this trial will help expand the use of current PET amyloid tracers and help many patients who currently undergo myocardial biopsy for the diagnosis of cardiac amyloid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patient is ≥ 18 years old at the time of the scan
- •Patient with known or suspected cardiac amyloidosis.
- •Patient is capable of complying with study procedures
排除标准
- •Patient is pregnant or nursing
- •Metallic implants (contraindicated for MRI)
- •History of renal insufficiency (only for MRI contrast administration)
研究组 & 干预措施
18F-Florbetaben (Neuraceq®) PET/MRI
Participants with known or suspected cardiac amyloidosis will be injected with 8 mCi of 18F-Florbetaben (Neuraceq®) and undergo the PET/MRI image acquisition 45-60 minute post-injection. PET and MRI data will be acquired simultaneously to ensure optimal timing and spatial correspondence between MRI and PET data. Total scan time will take approximately 60 minutes.
干预措施: 18F-Florbetaben (Neuraceq®) PET/MRI (Drug)
结局指标
主要结局
Number of participants with 18F-Florbetaben (Neuraceq®) uptake on Fused PET/MRI Images
时间窗: an estimated average of 2 hours
Diffuse (widespread), focal (point) and focal-on-diffuse (combination of the two) patterns of 18F-Florbetaben uptake will be considered positive findings indicating cardiac amyloidosis
次要结局
未报告次要终点
研究者
Andrei Iagaru
Associate Professor of Radiology - Nuclear Medicine
Stanford University