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.
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 known or suspicion of thrombus outside of the left atrial appendage.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
165
Injection of Copper-64 radiopeptide to detect thrombosis
Whole body imaging using Siemens mMR PET/MR scanner
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGComplete blood count
To model pharmacokinetics of \[64Cu\]FBP8 metabolism in healthy volunteers.
Time frame: 36 hours
Target to Background Ratio LAA
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.
Time frame: 4 hours
Target to Background Ratio
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 frame: 4 hours
Time activity curve
To evaluate human dosimetry and radiation burden in healthy volunteers.
Time frame: 48 hours
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A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer