Preliminary Evaluation of [64Cu]FBP8 in Healthy Individuals and Subjects With Known or at Risk of Developing Thrombosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Complete blood count
研究概览
简要总结
The purpose of the study is to evaluate a new radiotracer called 64Cu-FBP8 for PET-MR imaging of thrombosis. The tracer has the potential of detecting thrombosis anywhere in the body, for instance in the left atrial appendage of patients with atrial fibrillation, and thereby may provide a non-invasive alternative to the current standard-of-care methods.
详细描述
The primary objectives of this study are:
- To evaluate the safety of [64Cu]FBP8 and its whole body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers.
- To establish the accuracy of [64Cu]FBP8 -PET to detect left atrial thrombosis in patients with atrial fibrillation.
- To explore the feasibility of [64Cu]FBP8 -PET to detect thrombosis in patients with COVID-19.
- To explore the feasibility of [64Cu]FBP8 -PET to detect thrombosis in patients with cancer.
- To explore the feasibility of [64Cu]FBP8 -PET to detect thrombosis in patients with known or suspicion of thrombus outside of the left atrial appendage.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Healthy Volunteers
Twenty (20) healthy adult subjects will be injected with [64Cu]FBP8 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using PET/MR. Healthy subjects will undergo blood collection before, during, and after the scan. Healthy subjects will also undergo electrocardiogram before and after the scan. An interim review of the data will be conducted after the first six subjects receive the study agent and complete all safety assessments.
干预措施: [64Cu]FBP8 (Drug)
Healthy Volunteers
Twenty (20) healthy adult subjects will be injected with [64Cu]FBP8 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using PET/MR. Healthy subjects will undergo blood collection before, during, and after the scan. Healthy subjects will also undergo electrocardiogram before and after the scan. An interim review of the data will be conducted after the first six subjects receive the study agent and complete all safety assessments.
干预措施: PET/MR (Device)
Healthy Volunteers
Twenty (20) healthy adult subjects will be injected with [64Cu]FBP8 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using PET/MR. Healthy subjects will undergo blood collection before, during, and after the scan. Healthy subjects will also undergo electrocardiogram before and after the scan. An interim review of the data will be conducted after the first six subjects receive the study agent and complete all safety assessments.
干预措施: Blood Collection (Procedure)
Healthy Volunteers
Twenty (20) healthy adult subjects will be injected with [64Cu]FBP8 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using PET/MR. Healthy subjects will undergo blood collection before, during, and after the scan. Healthy subjects will also undergo electrocardiogram before and after the scan. An interim review of the data will be conducted after the first six subjects receive the study agent and complete all safety assessments.
干预措施: Electrocardiogram (Procedure)
Atrial Fibrillation Patients
Thirty-five (35) patients with LAA thrombus documented by TEE will be injected with [64Cu]FBP8 and imaged for LAA thrombus with MR-PET. The TEE studies in these patients will be part of their routine clinical care. Thirty-five (35) patients with atrial fibrillation and negative TEE will be injected with [64Cu]FBP8 and imaged for LAA thrombus. Forty (40) patients with atrial fibrillation who are scheduled for TEE in the upcoming 14 days will be injected with [64Cu]FBP8 and imaged for LAA thrombus.
干预措施: [64Cu]FBP8 (Drug)
Atrial Fibrillation Patients
Thirty-five (35) patients with LAA thrombus documented by TEE will be injected with [64Cu]FBP8 and imaged for LAA thrombus with MR-PET. The TEE studies in these patients will be part of their routine clinical care. Thirty-five (35) patients with atrial fibrillation and negative TEE will be injected with [64Cu]FBP8 and imaged for LAA thrombus. Forty (40) patients with atrial fibrillation who are scheduled for TEE in the upcoming 14 days will be injected with [64Cu]FBP8 and imaged for LAA thrombus.
干预措施: PET/MR (Device)
COVID-19 Patients
Thirty (30) COVID-19 patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
干预措施: [64Cu]FBP8 (Drug)
COVID-19 Patients
Thirty (30) COVID-19 patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
干预措施: PET/MR (Device)
Cancer Patients
Thirty (30) cancer patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
干预措施: [64Cu]FBP8 (Drug)
Cancer Patients
Thirty (30) cancer patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
干预措施: PET/MR (Device)
Other Thrombotic Condition Patients
Fifty (50) patients with other thrombotic conditions will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
干预措施: [64Cu]FBP8 (Drug)
Other Thrombotic Condition Patients
Fifty (50) patients with other thrombotic conditions will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
干预措施: PET/MR (Device)
结局指标
主要结局
Complete blood count
时间窗: 36 hours
To model pharmacokinetics of \[64Cu\]FBP8 metabolism in healthy volunteers.
Target to Background Ratio LAA
时间窗: 4 hours
To determine the signal threshold of \[64Cu\]FBP8 that produces the highest accuracy of \[64Cu\]FBP8 -PET to detect left atrial thrombosis in patients with atrial fibrillation.
Target to Background Ratio
时间窗: 4 hours
To determine the signal threshold of \[64Cu\]FBP8 that produces the highest accuracy of \[64Cu\]FBP8 -PET to detect thrombosis in patients with known thrombus or suspicion of thrombus.
Time activity curve
时间窗: 48 hours
To evaluate human dosimetry and radiation burden in healthy volunteers.
次要结局
未报告次要终点
研究者
Peter Caravan
Professor of Radiology
Massachusetts General Hospital