Positron Emission Tomography (PET) Imaging of Thrombosis

Purpose

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

  • Atrial Fibrillation
  • COVID-19
  • Cancer
  • Thrombosis

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Exclusion 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 exclusion criteria for Atrial Fibrillation Patient subjects:

- Stroke within the last 3 months;

- Myocardial infarction within the last 3 months;

- Cardiac or major surgery within the last 3 months;

- History of chest pain within the last 6 weeks unless followed by a subsequent stress
test or coronary angiography;

- History of syncope within the last 6 weeks;

- Heart rate persistently >120 bpm or persistently < 50 bpm;

- Presence of daytime pauses > 3s

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Healthy Volunteers
Twenty (20) healthy adult subjects will be injected with [64Cu]FBP8 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using PET/MR. Healthy subjects will undergo blood collection before, during, and after the scan. Healthy subjects will also undergo electrocardiogram before and after the scan. An interim review of the data will be conducted after the first six subjects receive the study agent and complete all safety assessments.
  • Drug: [64Cu]FBP8
    Injection of Copper-64 radiopeptide to detect thrombosis
    Other names:
    • 64Cu-FBP8
  • Device: PET/MR
    Whole body imaging using Siemens mMR PET/MR scanner
    Other names:
    • PET-MR
  • Procedure: Blood Collection
    A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
  • Procedure: Electrocardiogram
    A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer
    Other names:
    • ECG
Experimental
Atrial Fibrillation Patients
Thirty-five (35) patients with LAA thrombus documented by TEE will be injected with [64Cu]FBP8 and imaged for LAA thrombus with MR-PET. The TEE studies in these patients will be part of their routine clinical care. Thirty-five (35) patients with atrial fibrillation and negative TEE will be injected with [64Cu]FBP8 and imaged for LAA thrombus. Forty (40) patients with atrial fibrillation who are scheduled for TEE in the upcoming 14 days will be injected with [64Cu]FBP8 and imaged for LAA thrombus.
  • Drug: [64Cu]FBP8
    Injection of Copper-64 radiopeptide to detect thrombosis
    Other names:
    • 64Cu-FBP8
  • Device: PET/MR
    Whole body imaging using Siemens mMR PET/MR scanner
    Other names:
    • PET-MR
Experimental
COVID-19 Patients
Thirty (30) COVID-19 patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
  • Drug: [64Cu]FBP8
    Injection of Copper-64 radiopeptide to detect thrombosis
    Other names:
    • 64Cu-FBP8
  • Device: PET/MR
    Whole body imaging using Siemens mMR PET/MR scanner
    Other names:
    • PET-MR
Experimental
Cancer Patients
Thirty (30) cancer patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
  • Drug: [64Cu]FBP8
    Injection of Copper-64 radiopeptide to detect thrombosis
    Other names:
    • 64Cu-FBP8
  • Device: PET/MR
    Whole body imaging using Siemens mMR PET/MR scanner
    Other names:
    • PET-MR
Experimental
Other Thrombotic Condition Patients
Fifty (50) patients with other thrombotic conditions will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
  • Drug: [64Cu]FBP8
    Injection of Copper-64 radiopeptide to detect thrombosis
    Other names:
    • 64Cu-FBP8
  • Device: PET/MR
    Whole body imaging using Siemens mMR PET/MR scanner
    Other names:
    • PET-MR

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
David E Sosnovik, MD

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

David E Sosnovik, MD
617-724-3407
sosnovik@nmr.mgh.harvard.edu

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.