Actively Recruiting

Phase 1
Age: 18Years - 85Years
All Genders
Healthy Volunteers
NCT03830320

Positron Emission Tomography (PET) Imaging of Thrombosis

Led by Massachusetts General Hospital · Updated on 2026-02-27

165

Participants Needed

1

Research Sites

565 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Positron Emission Tomography (PET) Imaging of Thrombosis

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 85 years
  • For atrial fibrillation patients: history of atrial fibrillation or paroxysmal atrial fibrillation
  • For atrial fibrillation patients: Transesophageal echocardiogram (TEE) to evaluate left atrial appendage (LAA) within 14 days prior to enrollment or scheduled within 14 days
  • For COVID-19 patients: positive SARS-CoV-2 RNA test by RT-PCR within the last month and not requiring mechanical ventilation
  • For cancer patients: diagnosed with cancer
  • For other patients: ultrasound- or CT-confirmed or high likelihood of thrombus (e.g., elevated D-dimer)
  • For other patients: no thrombolytic treatment received
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Presence of electrical implants such as cardiac pacemaker or perfusion pump
  • Pregnant or breastfeeding (negative pregnancy test required for females of childbearing potential)
  • Claustrophobia
  • Radiation exposure exceeding 50 mSv in the prior 12 months
  • Unable to lie comfortably inside the PET scanner
  • Direct or indirect supervision by the principal investigator
  • Body weight over 300 lbs for MRI table or over 441 lbs for CT table
  • Metallic or electric implants contraindicated for MR-PET scanning
  • Inability to give written informed consent
  • Clinically unsuitable as determined by investigators
  • For atrial fibrillation patients: stroke, myocardial infarction, or major cardiac surgery within last 3 months
  • For atrial fibrillation patients: chest pain or syncope within last 6 weeks unless followed by stress test or angiography
  • For atrial fibrillation patients: persistent heart rate over 120 bpm or under 50 bpm
  • For atrial fibrillation patients: daytime pauses greater than 3 seconds

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

D

David E Sosnovik, MD

CONTACT

A

Anne L Philip, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

5

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