Preliminary Evaluation of [64Cu]FBP8 in Healthy Individuals and Subjects With Known or at Risk of Developing Thrombosis
Massachusetts General Hospital
Summary
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.
Description
The primary objectives of this study are: 1. To evaluate the safety of \[64Cu\]FBP8 and its whole body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers. 2. To establish the accuracy of \[64Cu\]FBP8 -PET to detect left atrial thrombosis in patients with atrial fibrillation. 3. To explore the feasibility of \[64Cu\]FBP8 -PET to detect thrombosis in patients with COVID-19. 4. To explore the feasibility of \[64Cu\]FBP8 -PET to detect thrombosis in patients with cancer. 5. To explore the feasibility of \[64Cu\]FBP8 -PET to detect thrombosis in patients with kn…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- Yes
For Atrial Fibrillation Patient subjects: * History of atrial fibrillation or paroxysmal atrial fibrillation; * Retrospective enrollment: TEE to evaluate LAA within the last 14 days, provided the anticoagulation regimen the patient is on is not changed after the TEE. If a patient has a negative TEE and continues the same stable anti-coagulation regimen he/she is on, then it is extremely unlikely that a new thrombus will develop in the left atrial appendage within the next two weeks. Likewise, if a patient not taking any anti-coagulation has a thrombus in the left atrial appendage, then it is…
Interventions
- Drug[64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
- DevicePET/MR
Whole body imaging using Siemens mMR PET/MR scanner
- ProcedureBlood Collection
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
- ProcedureElectrocardiogram
A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer
Location
- Massachusetts General HospitalBoston, Massachusetts