Preliminary Evaluation of [64Cu]FBP8 in Healthy Individuals and Subjects With Known or at Risk of Developing Thrombosis
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.
Detailed 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 known or suspicion of thrombus outside of the left atrial appendage.
Arms & 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
Outcome measures
Primary
Complete 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
Eligibility criteria
Study locations (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114
References
- Izquierdo-Garcia D, Desogere P, Philip AL, Mekkaoui C, Weiner RB, Catalano OA, Iris Chen YC, DeFaria Yeh D, Mansour M, Catana C, Caravan P, Sosnovik DE. Detection and Characterization of Thrombosis in Humans Using Fibrin-Targeted Positron Emission Tomography and Magnetic Resonance. JACC Cardiovasc Imaging. 2022 Mar;15(3):504-515. doi: 10.1016/j.jcmg.2021.08.009. Epub 2021 Oct 13.(PubMed)