Health TrialsbyHealthPanel

Positron Emission Tomography (PET) Imaging of Thrombosis

ConditionsAtrial FibrillationCOVID-19CancerThrombosis
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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • [64Cu]FBP8

    Drug

    Injection of Copper-64 radiopeptide to detect thrombosis

  • PET/MR

    Device

    Whole body imaging using Siemens mMR PET/MR scanner

  • Blood Collection

    Procedure/Surgery

    A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry

  • Electrocardiogram

    Procedure/Surgery

    A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer

Treatment groups

165 Participants
are divided into 5 treatment groups
Group A: Healthy VolunteersActive comparator 4 interventions
Group B: Atrial Fibrillation PatientsExperimental treatment 2 interventions
Group C: COVID-19 PatientsExperimental treatment 2 interventions
Group D: Cancer PatientsExperimental treatment 2 interventions
Group E: Other Thrombotic Condition PatientsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete blood count

To model pharmacokinetics of \[64Cu\]FBP8 metabolism in healthy volunteers.

Time frame
36 hours
2

Target to Background Ratio LAA

To determine the signal threshold of \[64Cu\]FBP8 that produces the highest accuracy of \[64Cu\]FBP8 -PET to detect left atrial thrombosis in patients with atrial fibrillation.

Time frame
4 hours
3

Target to Background Ratio

To determine the signal threshold of \[64Cu\]FBP8 that produces the highest accuracy of \[64Cu\]FBP8 -PET to detect thrombosis in patients with known thrombus or suspicion of thrombus.

Time frame
4 hours
4

Time activity curve

To evaluate human dosimetry and radiation burden in healthy volunteers.

Time frame
48 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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