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Positron Emission Tomography (PET) Imaging of Thrombosis | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT03830320•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.

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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 extremely unlikely that this thrombus will resolve spontaneously in the next 14 days if the patient continues not to take any anticoagulation. If the TEE leads to a change being made in the anticoagulation regimen (started/stopped/dose modified), then a time window of 72 hours from the TEE to PET imaging will be used. This scheme will ensure that the TEE can serve as an accurate gold standard;
•Prospective enrollment: TEE to evaluate LAA scheduled in upcoming 14 days;
•For COVID-19 Patient subjects:
•Positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper or lower respiratory tract analyzed by a certified lab with an FDA approved assay within the last month;
•Patient not requiring mechanical ventilation;
•For Cancer Patient subjects:
•Patient is diagnosed with cancer;
•For Other Patient subjects:
+2 more criteria

Exclusion Criteria

•Subjects less than 18 years of age;
•Electrical implants such as cardiac pacemaker or perfusion pump;
•Pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate);
•Claustrophobic reactions;
•Subjects will be excluded if research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
•Unable to lie comfortably on a bed inside the PET scanner;
•Subjects under direct or indirect (i.e. same department as PIs) supervision of the principal investigator;
•Body weight over the weight limit for the moving table (\> 300 lbs for the MRI table and \>441 lbs for the CT table);
•Metallic or electric implants contraindicated for MR-PET scanning when applicable;
•Does not have the ability to give written informed consent.
+8 more criteria

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

April 1, 2016

Primary Completion Date

January 31, 2027

Completion Date

January 31, 2027

Last Updated

February 27, 2026

Enrollment

165

ESTIMATED participants

Conditions

Atrial FibrillationCOVID-19CancerThrombosis

Interventions

[64Cu]FBP8

DRUG

PET/MR

DEVICE

Blood Collection

PROCEDURE

Electrocardiogram

PROCEDURE

Contacts

David E Sosnovik, MD

CONTACT

617-724-3407 sosnovik@nmr.mgh.harvard.edu

Anne L Philip, MPH

CONTACT

617-726-0431 alphilip@mgh.harvard.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Positron Emission Tomography (PET) Imaging of Thrombosis

Inclusion Criteria

Exclusion Criteria

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