Imaging of LAA Thrombosis

• Status: Unknown status
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

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;