North Shore/LIJ Health System has recently received FDA approval of an expanded access IND for Fluorodopa F-18 PET for Parkinsonian diseases.
FDA also approved the facility’s request to seek payment for the studies, however CMS approval must be granted for Medicare reimbursement. In the FDA –approved Expanded Access IND, 18F-dopa with PET is indicated to detect loss or no loss of dopaminergic neurons in the striatum in patients with parkinsonian syndromes. These two conditions are visually detected using a Fluorodopa F-18 PET scan.
Dr. Thomas Chaly has indicated willingness to share the IND for use as reference by other facilities seeking to submit similar applications. According to Dr. Chaly,
“Fluorodopa PET technology is superior to SPECT and the images are easy to interpret. The Striatal Occipital Ratio quantification (SOR) available with the PET technology will help to avoid false positives and negatives. Fluorodopa F 18 PET will reduces the scanning time for patients considerably. There are many advantages to Fluorodopa F 18 PET imaging. I am excited and many Medical centers will be very happy to have this.”
Facilities interested in the expanded access IND for Fluorodopa F-18 PET for Parkinsonian diseases can contact Dr. Chaly directly:
Thomas Chaly, PhD, FAIC
The Feinstein Institute for Medical Research
North Shore/LIJ Health System
350 Community Drive
Manhasset, New York, 11030