FDA greenlights Varian's FLASH clinical trial

By AuntMinnie.com staff writers

October 12, 2020 -- The U.S. Food and Drug Administration (FDA) gave radiation therapy vendor Varian Medical Systems an investigational device exemption (IDE) for the first-ever clinical trial of FLASH therapy, an experimental treatment modality delivering radiation therapy at ultrahigh dose rates.

The ultrahigh radiation doses in FLASH therapy are delivered in typically less than one second and may be more than 100 times faster than conventional radiation therapy, according to Varian. The clinical trial, dubbed FAST-01 (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases), will involve the investigational use of a modified version of Varian's ProBeam particle accelerator.

Researchers will enroll 10 patients with bone metastases and evaluate clinical workflow feasibility, treatment-related side effects, and treatment efficacy as determined by participants' pain relief. The company expects to enroll the first patient by the end of the year.

The idea behind FLASH therapy is to deliver radiation to patients in fewer fractions, potentially reducing side effects and the number of visits needed to travel to receive treatments.


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