Imaging of LAA 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 in the left atrial appendage of patients with atrial fibrillation, thereby may provide a non-invasive alternative to the current standard-of-care, transesophageal echocardiography.

Condition

  • Atrial Fibrillation

Eligibility

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

Inclusion Criteria

For Healthy subjects:

- Must be 18 years of age or older;

- Must be deemed healthy at screening visit as determined by the physician investigator or nurse practitioner, based on the following assessments at Screening: physical examination, medical history and vital signs;

- No known history of atrial fibrillation or thrombosis;

- Negative Drug Screen;

- Have the ability to give written informed consent.

For Patient subjects:

- History of atrial fibrillation or paroxysmal atrial fibrillation;

- TEE to evaluate LAA within last 72 hours;

- Negative Drug Screen;

- Have the ability to give written informed consent.

Exclusion Criteria

  • Subjects less than 18 years of age;
  • Electrical implants such as cardiac pacemaker or perfusion pump;
  • Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;
  • Pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required 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 MR-PET;
  • Subjects under direct or indirect (i.e. same department as PIs) supervision of the principal investigator;
  • Body weight of > 300 lbs (weight limit of the MRI table);
  • Failed urine drug screen;
  • Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures);
  • 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
In the first stage, 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
In the second stage, forty (40) 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.
  • 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

NCT ID
NCT03830320
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.