UC San Francisco study data was instrumental in today’s approval by the Food and Drug Administration (FDA) of a PET imaging agent that helps physicians evaluate gliomas, a form of brain cancer.
The approval of floretyrosine F 18 (18F-FET) was supported by prospective clinical trial data generated at UCSF through a multi-year study. The agent addresses a persistent challenge in caring for people with gliomas: determining whether changes seen on conventional imaging represent tumor growth or changes caused by treatment.
“Molecular imaging is an incredibly powerful tool for characterizing disease in ways conventional imaging sometimes cannot,” said study sponsor Thomas Hope, MD, director of Molecular Therapy in UCSF’s Department of Radiology and Biomedical Imaging.
Gliomas are the most common primary tumors of the central nervous system, with approximately 24,000 people diagnosed in the U.S. each year. They can infiltrate surrounding brain tissue, making them particularly difficult to evaluate and treat.
“Patients and their families can face tremendous uncertainty when an MRI changes and we can’t confidently determine why,” said UCSF Health neuro-oncologist Nancy Ann Oberheim Bush, MD. “Having better non-invasive tools to characterize what is happening in the brain can help us make more informed treatment decisions and give patients clearer answers about their disease.”
From academia to industry
The FDA approval grew out of a UCSF clinical trial that evaluated 18F-FET PET in patients with brain tumors. UCSF subsequently made data from the trial available to Telix Pharmaceuticals. Javier Villanueva-Meyer, MD, was the lead neuroradiologist for the trial. UCSF and Telix collaborated to help translate that academic research into a product that could meet FDA requirements. “It’s an exciting example of how academic research and industry can work together to move a promising diagnostic tool from a clinical study toward broader patient care,” said Hope.
Contrast-enhanced MRI is the standard imaging method used to assess gliomas, but it cannot always reliably distinguish active tumor from changes in the brain caused by radiation, chemotherapy, or other treatments. The two can look similar on an MRI.