Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
Brief summary
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.
Interventions
DRUGBFPET
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.
Sponsors
Fluoropharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must provide written informed consent prior to any study related procedures; * Subjects must be ≥ 21 and ≤ 85 years of age; * Subjects must have known or suspected CAD documented by ≥2 segments of reversible perfusion abnormalities on a SPECT (MPI)study
Exclusion criteria
* Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination; * Blood pressure over 180/100mmHg * Acute changes in comparison to most recent ECG; * Recent (within 3 months) cardiac arrest, unstable angina, cerebro-vascular accident (CVA), CABG or PCI * Any pacemaker or defibrillator implanted within the last three months; * Inability to remain in camera for approximately 60 minutes * Bronchospasm * Serum creatinine \> 2 mg/dL; * Cancer patients who have received chemotherapy or radiation therapy within the past 60 days. * Any exposure to any investigational drug(s) or medical device(s) within four (4) weeks prior to imaging study; * Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination. * NYHA Class III or IV Congestive heart failure; * Subject has symptomatic hypotension * Allergic or intolerant to aminophylline, nitroglycerin or metoprolol * Allergic or intolerant to regadenoson or any of its excipients * Prior participants in the study. * Female subjects only: Positive serum and/or urine pregnancy test or is lactating or the possibility of pregnancy cannot be ruled out prior to dosing. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of BFPET | Up to 30 days | To evaluate the diagnostic performance of BFPET as a PET agent assessment of myocardial perfusion in known or suspected CAD subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety endpoints - ECG, physical examinations, vital signs, laboratory and adverse event assessments | Up to 10 days | Vital signs, ECG, laboratory assessments - up to 24 hours post injection, adverse event assessment at all study visits (7-10 days) post BFPET administration |
Countries
United States
Contacts
Primary ContactEd Lyons
Outcome results
None listed