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Sponsored by: |
Fluoropharma, Inc. |
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Information provided by: | Fluoropharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00413647 |
Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85. Nine normal controls will undergo repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging only.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Drug: CardioPET |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety Study |
Official Title: | A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of CardioPET™ as a PET Tracer for Detection of Coronary Artery Disease |
Estimated Enrollment: | 21 |
Study Start Date: | September 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
CardioPET™ is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body.
Study Procedures:
Visit 1: Screening - Eligibility determination
Visit 2: Injection and PET Imaging
Visit 3: Follow-up Visit
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Normal Healthy Volunteers:
Coronary Artery Disease (CAD) subjects:
Exclusion Criteria:
Normal Healthy Volunteers:
Coronary Artery Disease (CAD) Subjects:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Alan J. Fischman, MD, PhD | Massachusetts General Hospital |
Study ID Numbers: | CardioPET P-01 |
Study First Received: | December 18, 2006 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00413647 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CardioPET Coronary Artery Disease Electrocardiogram Radiation Dosimetry |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Healthy Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |