PET Fibrin Imaging of DVT and PE
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|ClinicalTrials.gov Identifier: NCT04022915|
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism Deep Vein Thrombosis Venous Thromboembolism||Drug: 64Cu-FBP8 Diagnostic Test: PET-CT imaging||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects with acute pulmonary embolism meeting the inclusion criteria will be enrolled.|
|Masking:||None (Open Label)|
|Official Title:||PET Fibrin Imaging of DVT and PE|
|Actual Study Start Date :||May 13, 2019|
|Estimated Primary Completion Date :||May 13, 2023|
|Estimated Study Completion Date :||May 31, 2024|
Experimental: Acute pulmonary embolism
Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging.
Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject.
Diagnostic Test: PET-CT imaging
All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
- Location of the thrombus within the lungs [ Time Frame: 4 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 [ Time Frame: 4 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 and upper extremity [ Time Frame: 4 hours ]The prevalence of high 64Cu-FBP8 fibrin activity in the pelvic ROI and upper extremity ROI's will be reported.
- Correlation between normalized 64Cu-FBP8 fibrin activity and plasma D-dimer [ Time Frame: 4 hours ]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.
- Overall clot burden within the lungs [ Time Frame: 4 hours ]Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the lungs.
- Overall clot burden within the thigh [ Time Frame: 4 hours ]Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the thigh.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022915
|Contact: Tilo Winkler, PhDfirstname.lastname@example.org|
|Contact: Mamary T Kone, MD, MPHemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Tilo Winkler, PhD 617-724-4083 firstname.lastname@example.org|
|Principal Investigator:||Tilo Winkler, PhD||Massachusetts General Hospital|