Positron Emission Tomography (PET) Imaging of Thrombosis

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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;

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • [64Cu]FBP8
  • PET/MR
  • Blood Collection
  • Electrocardiogram

Treatment groups

165 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator