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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
6
Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject.
All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
Massachusetts General Hospital
Boston, Massachusetts, United States
Location of the Thrombus Within the Lungs
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.
Time frame: 72 hours
Location of Clot Burden Measurements Within the Thigh
To determine the location of the thrombus ROI within the thigh using PET-CT imaging in comparison to the clot on venous duplex ultrasound.
Time frame: 72 hours
Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity
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.
Time frame: 4 hours
Correlation Between Normalized 64Cu-FBP8 Fibrin Activity and Plasma D-dimer
Correlation of the total fibrin activity in the imaged fields, excluding the liver, gallbladder, kidneys and urinary bladder normalized by injected dose with the plasma D-dimer. Outcome measure is the value of the Pearson correlation coefficient .
Time frame: 4 hours
Overall Clot Burden Within the Lungs
Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the lungs. This is reported in 4 different ways: 1. TBRmean of the PE which is the ratio of the mean PET signal in the pulmonary embolus (clot) divided by the mean PET signal in the blood pool 2. TBRmax of the PE which is the ratio of the maximum PET signal in the pulmonary embolus (clot) divided by the mean PET signal in the blood pool 3. SUVmean of the PE which is the mean standardized uptake value (SUV) in the pulmonary embolus (clot) 4. SUVmax of the PE which is the maximum standardized uptake value (SUV) in the pulmonary embolus (clot)
Time frame: 4 hours
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Overall Clot Burden Within the Thigh
Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the thigh. This is reported as: TBRmean of the thrombus which is the ratio of the mean PET signal in the thrombus within the thigh divided by the mean PET signal in the blood pool
Time frame: 4 hours