Imaging of LAA Thrombosis

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.

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;