Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dotatate SUVmax activity in the heart
研究概览
简要总结
Gallium-68 DOTATATE is a radioactive tracer, a type of imaging drug that is labeled with a radioactive tag and injected into the body, which is approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors. The study will see how the tracer is taken up in your heart before and after treatment using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). Investigators are doing this research study to find out if DOTATATE can help doctors diagnose people with cardiac (heart) sarcoidosis better as well as serve as a follow-up monitoring tool for a response to therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants will be ≥ 18 years of age
- •History of biopsy-proven sarcoidosis OR suspected sarcoidosis based on standard clinical imaging (e.g. FDG PET/CT, MRI) without biopsy confirmation
- •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 fusion
- •Any cardiac arrhythmia
- •Chest pain, dyspnea or syncope without clear etiology
- •FDG PET/CT scan demonstrating abnormal myocardial FDG uptake
- •Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures
排除标准
- •Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
- •History of neuroendocrine tumors
- •Currently taking the medication Octreotide
- •Currently on total parenteral nutrition (TPN)
- •Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- •Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
研究组 & 干预措施
Patients with Suspected Cardiac Sarcoidosis
patients with biopsy proven or suspected sarcoidosis (based on standard clinical imaging findings).
干预措施: Gallium-68 DOTATATE (Drug)
结局指标
主要结局
Dotatate SUVmax activity in the heart
时间窗: 3 years
The standardized uptake value (SUV) is a nuclear medicine unit commonly used to distinguish between "normal" and "abnormal" levels of tissue uptake.
次要结局
- Change in Dotatate SUVmax activity in the heart on follow-up PET/CT scan compared to baseline(3 years)
研究者
Paco Bravo, MD
Assistant Professor of Radiology at the Hospital of the University of Pennsylvania
University of Pennsylvania