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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
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.
Time frame: Up to 30 days
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
Time frame: Up to 10 days
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