A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of BFPET as a Potential Myocardial Perfusion Imaging (MPI) Agent for PET|
- Change in blood pressure. Safety Biodistribution Radiation dosimetry [ 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. ] [ Designated as safety issue: Yes ]
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.
- Performance characteristics of BFPET as a PET tracer for myocardial imaging. [ Time Frame: 30, 60, 120, and 240 seconds. ] [ Designated as safety issue: No ]Whole body imaging measures radiation dosimetry at rest and under pharmacologic stress
|Study Start Date:||March 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Henry Gewirtz, M.D.||Massachusetts General Hospital|