Coronary Artery Disease
Conditions
Keywords
BFPET, Coronary Artery Disease, Myocardial Perfusion Imaging, Radiation Dosimetry
Brief summary
Safety and dosimetry of BFPET™ will be evaluated in healthy volunteers and Coronary Artery Disease (CAD) patients , male or female and of age ranging between 20-80 years old.
Detailed description
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
Interventions
DRUGBFPET
Sponsors
Fluoropharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
NORMAL HEALTHY VOLUNTEERS Inclusion Criteria 1. Subject must provide written informed consent prior to any study related procedures; 2. Subject must be ≥ 20 and ≤ 80 years of age; 3. Subject must have a serum creatinine within the investigational site's normal range. 4. Subject must have liver function tests \< 1.5 times the investigational site's normal range. 5. Subject must have a hematocrit level within 5% of the investigational site's normal range.
Exclusion criteria
1. Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination; 2. Any clinically significant abnormality in the screening laboratory tests or ECG; 3. Any exposure to any investigational drugs within four (4) weeks prior to Visit 1; 4. Any exposure to investigational radiopharmaceuticals within four (4) weeks prior to the date of Visit 1; 5. Any new prescription medications within four (4) weeks of Visit 1; 6. 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. 7. Subject has experienced any allergic reaction to similar radiofluorinated compounds or agents. CORONARY ARTERY DISEASE (CAD) SUBJECTS Inclusion Criteria: 1. Subjects must provide written informed consent prior to any study related procedures; 2. Subjects must be ≥ 20 and ≤ 80 years of age; 3. 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 study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure. Safety Biodistribution Radiation dosimetry | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance characteristics of BFPET as a PET tracer for myocardial imaging. | 30, 60, 120, and 240 seconds. | Whole body imaging measures radiation dosimetry at rest and under pharmacologic stress |
Countries
United States
Outcome results
None listed