PET Fibrin Imaging of DVT and PE
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Location of the Thrombus Within the Lungs
研究概览
简要总结
This study aims to investigate a novel positron emission tomography(PET)-probe for imaging of fresh intravascular blood clots in pulmonary embolism (PE) and deep venous thrombosis (DVT).
详细描述
Venous thromboembolism (VTE) is one of the most common causes of death in the United States, resulting in more than 100,000 deaths annually. Current diagnostic techniques rely on indirect measures of clot for diagnosis and therefore suffer from the problems of both under and overdiagnosis and cannot always be performed on patients with renal failure and lung disease. In this study, we will use the novel fibrin-specific probe 64CU-FBP8 (Copper-64 labeled fibrin binding probe 8) for PET imaging of fresh blood clots in PE and DVT. Our long-term goal is to establish a novel thrombus body scan (TBS) using 64CU-FBP8 for PET imaging to overcome the limitations of indirect venous thromboembolism diagnosis, and, with one single test, provide a total-body assessment of fresh intravascular clot.
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
- •18 years of age or older with a clinically significant pulmonary embolus (PE) confirmed by a filling defect in CT angiography (CTA), and
- •Subjects must receive the radiotracer injection within 72 hours of their diagnosis.
排除标准
- •Subjects < 18 years of age
- •Time of expected radiotracer injection > 72 hours from the time of a positive venous duplex ultrasound or CT- angiogram
- •Women subjects of childbearing potential who are pregnant, seeking to become pregnant, or have a positive serum pregnancy (beta-HCG) test
- •Unable to lie flat for 45 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis, dyspnea),
- •Weight that exceeds the PET camera table limit (300 kg)
- •The subject will not be enrolled in the study if the radiation exposure for research studies during the prior 12 months, combined with the exposure from this study would exceed 50 mSv (millisievert).
- •Due to the radiation exposure from imaging studies, all women of childbearing potential will be required to have a negative serum pregnancy test performed prior to any imaging procedures on the same day (if not already done that day). Patients with a positive serum pregnancy test will be excluded. Breast feeding women will also be excluded.
- •A pre-existing condition or use of a medication including vasopressors and tPA (tissue Plasminogen Activator) that in the opinion of the investigator may place the subject at a substantially increased risk
- •Hemodynamic instability, including requiring escalating doses of vasopressor medication.
- •No groups designated as "special vulnerable populations" will be studied.
- •No exclusions will be made based on race, sex, or ethnic origin.
- •64Cu-FBP8 (Copper-64 labeled fibrin binding probe 8) is cleared by the kidneys, patients with eGFR (estimated Glomerular Filtration Rate ) < 30 will be excluded.
研究组 & 干预措施
Acute pulmonary embolism
Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging.
干预措施: 64Cu-FBP8 (Drug)
Acute pulmonary embolism
Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging.
干预措施: PET-CT imaging (Diagnostic Test)
结局指标
主要结局
Location of the Thrombus Within the Lungs
时间窗: 72 hours
To determine the location of the thrombus regions of interest (ROIs) within the lungs using PET-CT imaging in comparison to the ROI of filling defects on CT-angiogram.
Location of Clot Burden Measurements Within the Thigh
时间窗: 72 hours
To determine the location of the thrombus ROI within the thigh using PET-CT imaging in comparison to the clot on venous duplex ultrasound.
Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity
时间窗: 4 hours
The presence or absence of blood clots as assessed by high 64Cu-FBP8 fibrin activity in the pelvic veins and upper extremities will be reported.
次要结局
- Correlation Between Normalized 64Cu-FBP8 Fibrin Activity and Plasma D-dimer(4 hours)
- Overall Clot Burden Within the Lungs(4 hours)
- Overall Clot Burden Within the Thigh(4 hours)
研究者
Peter Caravan
Associate Professor of Radiology
Massachusetts General Hospital