A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET
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|ClinicalTrials.gov Identifier: NCT00733460|
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : June 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: BFPET||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
- 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. ]
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. ]Whole body imaging measures radiation dosimetry at rest and under pharmacologic stress
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733460
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Henry Gewirtz, M.D.||Massachusetts General Hospital|