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BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in subjects with known or suspected coronary artery disease (CAD) as compared to standard nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known or suspected CAD subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BFPET | Experimental | BFPET will be administered as a single intravenous injection of up to 2 mCi (74 MBq) at rest and a single intravenous injection of up to 8mCi (296 MBq) following a stress protocol. Total amount not to exceed 10mCi (370 MBq). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BFPET | Drug | Sterile study drug will be delivered in individual dosage vials labeled and calibrated to approximately 2 mCi (74MBq) for the rest imaging and up to 8 mCi (296 MBq) for the stress imaging at the time of injection. The drug will be administered intravenously by bolus injection over 10 seconds into a peripheral vein to which access has been secured followed by saline flush. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of BFPET | To evaluate the diagnostic performance of BFPET as a PET agent assessment of myocardial perfusion in known or suspected CAD subjects. | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Primary safety endpoints - ECG, physical examinations, vital signs, laboratory and adverse event assessments | Vital signs, ECG, laboratory assessments - up to 24 hours post injection, adverse event assessment at all study visits (7-10 days) post BFPET administration | Up to 10 days |
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Inclusion Criteria:
Exclusion Criteria
Females not of child-bearing potential require confirmatory documentation in their medical records or must have a negative pregnancy test within 4 hours prior to receiving the test drug and agree to use an acceptable form of birth control for at least 30 days following BFPET administration.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ed Lyons | Contact | 973-744-1565 | ELyons@Fluoropharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Georges El Fakhri, Ph.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 |
| D017202 | Myocardial Ischemia |
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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