Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Participants Characterized by Abnormal or Negative Uptake
研究概览
简要总结
The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can help doctors diagnose people with cardiac sarcoidosis better.
OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 or older
- •Documentation of biopsy-proven sarcoidosis OR patients with typical findings on FDG PET and MRI without previous biopsy
- •Clinical suspicion of cardiac involvement defined as the presence of any of the following: high-degree A-V nodal block, complete bundle branch block, reduced left or right ventricular systolic function, any cardiac arrhythmia, and/or unexplained chest pain, dyspnea or syncope
- •PET/CT imaging demonstrating abnormal myocardial FDG uptake consistent with active inflammatory myocardium.
排除标准
- •Initiation of steroids or any other immunosuppressive medication(s) following the completion of FDG-PET, as these medications, in theory, may subsequently suppress OctreoScan or DOTATATE uptake in the heart.
- •Patients with history of neuroendocrine tumors (specially insulinomas)
- •Patients taking the medication Octreotide
- •Patients on total parenteral nutrition (TPN)
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
Indium-111 Pentreotide (OctreoScan)
Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Indium-111 Pentreotide (OctreoScan). The imaging protocol will consist of imaging at 4 and 24 hours after OctreoScan injection.
干预措施: Indium-111 Pentreotide (Drug)
Gallium-68 DOTATATE
Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Gallium-68 DOTATATE. The imaging protocol will consist of imaging 1 hour after injection for DOTATATE.
干预措施: Gallium-68 DOTATATE (Drug)
结局指标
主要结局
Number of Participants Characterized by Abnormal or Negative Uptake
时间窗: 1 hour
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.
次要结局
- Effect of Treatment(1 hour)
研究者
Marcelo F. Di Carli, MD, FACC
Chief of Nuclear Medicine
Brigham and Women's Hospital