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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
21
Massachusetts General Hospital
Boston, Massachusetts, United States
Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment.
Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.
Time frame: Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events).
Performance characteristics of CardioPET as a PET tracer for myocardial imaging.
Normal healthy volunteers and CAD subjects for Cardiac Imaging Only.
Time frame: 0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min.
Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data
Time frame: Baseline, 15 second time frames for first 2 minutes, 1 min. time frame for next 8 min., 2 min frames for remainder of 60 min study.
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