Status:
COMPLETED
A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET
Lead Sponsor:
Fluoropharma, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00733460
Start Date
March 1 2008
End Date
January 1 2012
Last Update
June 10 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114