A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET

Study Procedures:

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

NORMAL HEALTHY VOLUNTEERS Inclusion Criteria

• Subject must provide written informed consent prior to any study related procedures;
• Subject must be ≥ 20 and ≤ 80 years of age;
• Subject must have a serum creatinine within the investigational site's normal range.
• Subject must have liver function tests < 1.5 times the investigational site's normal range.
• Subject must have a hematocrit level within 5% of the investigational site's normal range.

Exclusion criteria

• Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination;
• Any clinically significant abnormality in the screening laboratory tests or ECG;
• Any exposure to any investigational drugs within four (4) weeks prior to Visit 1;
• Any exposure to investigational radiopharmaceuticals within four (4) weeks prior to the date of Visit 1;
• Any new prescription medications within four (4) weeks of Visit 1;
• Subject has a Positive (+) Serum Pregnancy Test, or the possibility of pregnancy cannot be ruled out prior to dosing or is breast-feeding. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH.
• Subject has experienced any allergic reaction to similar radiofluorinated compounds or agents.

CORONARY ARTERY DISEASE (CAD) SUBJECTS

Inclusion criteria

• Subjects must provide written informed consent prior to any study related procedures;
• Subjects must be ≥ 20 and ≤ 80 years of age;
• Subjects must have history of CAD documented by an abnormal stress myocardial perfusion imaging (MPI) study and cardiac catheterization within 6 months of the BFPET studyExclusion Criteria

Exclusion criteria

• Subject has a Positive (+) Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing;
• Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
• Coronary artery bypass graft (CABG) within 6 months;
• Percutaneous coronary intervention (PCI), with stent placement within six months;
• Blood pressure over 180/100;
• Acute changes in ECG;
• Recent (within 3 months) cardiac arrest, unstable angina, myocardial infarction, cerebro-vascular accident (CVA), any general anesthesia procedure, any surgical procedures;
• Any implanted pacemaker or defibrillator use within the last three months;
• Inability to remain in camera for approximately 60 minutes (Smokers and COPD are included as long as they can breath in PET camera and not taking O2 through nasal canula);
• History of Diabetes Mellitus;
• Serum creatinine > 2 mg/dL;
• All cancer patients;
• Body Mass Index (BMI) is over 35;
• Any exposure to any investigational drugs or medical device within four (4) weeks prior to imaging study;
• Any exposure to radiopharmaceuticals within four (4) weeks prior to the date of imaging study;