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This Article Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Google Scholar Articles by Kardan, A. Articles by Fischman, A. PubMed Articles by Kardan, A. Articles by Fischman, A.

A phase I study to evaluate the safety and biodistribution of CardioPET as a new cardiac PET tracer: Studies in normal subjects

¹ Nuclear Medicine, Massachusetts General Hospital, Boston, Massachusetts

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Objectives: CardioPET (trans-9-[¹⁸F]fluoro-3,4-methyleneheptadecanoic acid) is a modified fatty acid closely resembling naturally occurring fatty acids (FFAs). FFAs are the major source of energy for healthy myocardium where they are transported into the mitochondria and subsequently metabolized via β-oxidation. CardioPET undergoes metabolic trapping in heart tissue similar to that of 2-fluoro-2-deoxy-D-glucose (2FDG). To evaluate the biodistribution and safety of CardioPET in normal healthy volunteers, male and female subjects, ages 50-85, were studied.

Methods: A 3 day study protocol included: day 1, subjects were screened and eligible subjects were enrolled; day 2, subjects underwent CardioPET injection and PET imaging; day 3, follow up. Primary safety endpoints included: vital signs, physical examinations, 12-Lead Electrocardiograms, 24-Hour Holter Monitoring, and clinical laboratory tests (blood and urine). Imaging entailed a positioning and attenuation scan, followed by injection of approximately 10 mCi (370 mBq) of CardioPET and serial whole body images over 90 minutes.

Results: CardioPET injection was safe and without adverse event in all 6 subjects. All scans demonstrated excellent cardiac image quality. Calculated radiation dosimetry identified the liver as the target organ (average dose 53.3mRAD/mCi) with the whole body effective dose as an average of 75.94 mREM/mCi. Liver-to-blood ratios in subjects varied from 4:1 to 2:1. Heart uptake remained constant for 90 minutes, while liver activity demonstrated washout.

Conclusions: CardioPET injection in healthy voluteers is safe and demonstrates biodistribution with utility for heart and liver imaging. Safety, dosimetry, and imaging data will be presented.

Research Support: Fluoropharma Inc.

This Article Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Google Scholar Articles by Kardan, A. Articles by Fischman, A. PubMed Articles by Kardan, A. Articles by Fischman, A.