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Sponsored by: |
Fluoropharma, Inc. |
---|---|
Information provided by: | Fluoropharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00733460 |
Safety and dosimetry for BFPET™ will be evaluated in healthy volunteers, male or female and of age ranging between 20-80 years old. Six healthy subjects will undergo whole body imaging for biodistribution and dosimetry estimation. Another six healthy subjects will undergo heart imaging only, in order to evaluate the performance of BFPET as an imaging agent.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Drug: BFPET |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of BFPET as a Potential Myocardial Perfusion Imaging (MPI) Agent for PET |
Enrollment: | 12 |
Study Start Date: | March 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects must meet all of the following criteria to be enrolled in the study:
Exclusion Criteria:
Subjects having any of the following criteria at the time of enrollment will be excluded from study entry:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Alan J Fischman, M.D., Ph.D. | Massachusetts General Hospital |
Study ID Numbers: | BFPET P-01 |
Study First Received: | August 12, 2008 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00733460 History of Changes |
Health Authority: | United States: Food and Drug Administration |
BFPET Coronary Artery Disease Myocardial Perfusion Imaging Radiation Dosimetry |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |