Safety and dosimetry of BFPET™ will be evaluated in healthy volunteers and Coronary Artery Disease (CAD) patients , male or female and of age ranging between 20-80 years old.
Study Procedures: Visit 1: Screening - Eligibility determination Visit 2 (within 14 days post screening): Injection of BFPET™ and PET Imaging Visit 3 (within 24-48 hours post dose): Follow-up Visit
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
Massachusetts General Hospital
Boston, Massachusetts, United States
Change in blood pressure. Safety Biodistribution Radiation dosimetry
Change in vital signs, physical examination, ECG measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose. Change in 12-lead Electrocardiogram measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose. Change in 24-hour Holter (initiated 2 hours pre-dose, continuous for 24 hours, time stop recorded. Change in dosimetry sampling (blood and urine)blood measured at time 0 (immediately following injection), 1,5, 15, 30, 60, 90 minutes. Adverse event assessment immediate post dose, 24-48 hours and 7 days post-dose.
Time frame: pre-dose, post-dose 0, 1, 5, 15, 30, 60 and 90 minutes, 2 hours, 24-48 hours post-dose and 7 days post-dose.
Performance characteristics of BFPET as a PET tracer for myocardial imaging.
Whole body imaging measures radiation dosimetry at rest and under pharmacologic stress
Time frame: 30, 60, 120, and 240 seconds.
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