Trials / Recruiting
RecruitingNCT03830320
Positron Emission Tomography (PET) Imaging of Thrombosis
Preliminary Evaluation of [64Cu]FBP8 in Healthy Individuals and Subjects With Known or at Risk of Developing Thrombosis
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [64Cu]FBP8 | Injection of Copper-64 radiopeptide to detect thrombosis |
| DEVICE | PET/MR | Whole body imaging using Siemens mMR PET/MR scanner |
| PROCEDURE | Blood Collection | A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry |
| PROCEDURE | Electrocardiogram | A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2027-01-31
- Completion
- 2027-01-31
- First posted
- 2019-02-05
- Last updated
- 2026-02-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03830320. Inclusion in this directory is not an endorsement.