18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of Participants With 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Cardiac Involvement of Sarcoidosis
研究概览
简要总结
The investigators will evaluate the detection of cardiac sarcoidosis or inflammation using 18F-FSPG PET/MRI (or PET/CT for participants with metal implants).
详细描述
PET/MRI scans will be performed with a whole-body PET/MR imaging system capable of simultaneous PET and MR imaging (SIGNA, GE Healthcare, Milwaukee, WI). Approximately 45-60 minutes after IV injection of 8 mCi of 18F-FSPG, PET emission scanning and MRI acquisition T1 weighted scanning will begin imaging both whole body and the heart.
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 sarcoidosis.
- •Patient is capable of complying with study procedures
- •Patient can remain still for duration of imaging procedure
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-FSPG
Patients receive 18F-FSPG for detection of Cardiac Sarcoidosis or Inflammation
干预措施: 18F-FSPG (Drug)
结局指标
主要结局
Number of Participants With 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Cardiac Involvement of Sarcoidosis
时间窗: average approximately 2 hours
Diffuse (widespread), focal (point) and focal-on-diffuse (combination of the two) patterns of 18F-FSPG uptake will be considered to be positive findings indicating cardiac involvement of sarcoidosis or inflammation
次要结局
- Number of Participants With Evidence of Whole Body 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Extra-cardiac Sarcoidosis(average approximately 2 hours)
研究者
Andrei Iagaru
Associate Professor of Radiology
Stanford University