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Safety and dosimetry of BFPETâ„¢ 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 BFPETâ„¢ and PET Imaging
Visit 3 (within 24-48 hours post dose): Follow-up Visit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BF-PET | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BFPET | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance characteristics of BFPET as a PET tracer for myocardial imaging. | Whole body imaging measures radiation dosimetry at rest and under pharmacologic stress | 30, 60, 120, and 240 seconds. |
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NORMAL HEALTHY VOLUNTEERS Inclusion Criteria
Exclusion Criteria:
CORONARY ARTERY DISEASE (CAD) SUBJECTS
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Gewirtz, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |