Positron Emission Tomography (PET) Imaging of Thrombosis

Study 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.

Ask AI to explain this study

Start here

Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studied[64Cu]FBP8 and PET/MR

Plus 2 other study approaches.

Who it may be forAtrial Fibrillation · COVID-19

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 27, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Massachusetts General Hospital

Study sponsor

Study overview

What this study is about

Purpose: Diagnostic
Study type: Interventional
Phase: Phase 1
Sponsor: Massachusetts General Hospital
Interventions being studied: Drug: [64Cu]FBP8; Device: PET/MR; Procedure: Blood Collection; Procedure: Electrocardiogram

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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:
Ultrasound- or CT-confirmed or high likelihood of thrombus (e.g., elevated D-dimer)
Has not received thrombolytics

Reasons someone may not be able to joinExclusion criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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.
Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures); Additional

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Massachusetts General HospitalBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 27, 2026. Always confirm current availability with the study team.

View original record ↗