PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Microvascular Damage/Endothelial Dysfunction
研究概览
简要总结
Researchers are trying to determine the side effects on the heart from immune checkpoint inhibitor (ICI) treatment in patients with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •First time administration of ICI
- •Willing and able to return in 4-6 weeks for follow-up study
- •Patients with previous heart conditions included (while this may impact MFR the delta MFR is what we are assessing)
排除标准
- •Age < 18 years
- •Women who are pregnant, or breast-feeding.
- •Unable or unwilling to give consent to undergo PET/CT.
研究组 & 干预措施
Checkpoint Inhibitor (ICI)
Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.
干预措施: PET/CT (Diagnostic Test)
Checkpoint Inhibitor (ICI)
Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.
干预措施: radioactive drug (tracer) (Drug)
结局指标
主要结局
Microvascular Damage/Endothelial Dysfunction
时间窗: 6 weeks
Number of subjects to develop microvascular damage/endothelial dysfunction as determined by the PET/CT scan. PET-CT MFR used to assess dynamic changes in MFR that occur pre and post initiation of ICI and thereby potentially identify early cardiotoxicity in patients who might be more prone to more devastating IRAEs such as myocarditis.
次要结局
未报告次要终点
研究者
John P. Bois, M.D.
Principal Investigator
Mayo Clinic