FDA grants IDE clearance for next-phase trial of ‘Flash’ radiation therapy
A cancer-care technology company that was acquired by one of the world’s largest imaging OEMs a year ago has received an Investigational Device Exemption from the FDA.
The IDE will allow the company to advance its ongoing research into Flash therapy—which delivers ultra-high-dose radiation therapy in one second or less—as a firstline treatment for thoracic bone metastases.
Palo Alto, Calif.-based Varian, which became part of Siemens Healthineers in the first half of 2021, announced the go-ahead June 27.
The company says it will work on the technology in a trial called FAST-02. The acronym stands for FeAsibility Study of Flash therapy for the Treatment of symptomatic bone metastases.
Varian began clinically testing the technique in its FAST-01 trial and used data from that phase to earn the new IDE.
Varian says it expects to enroll 10 patients suffering with thoracic bone metastases for FAST-02, documenting evidence of safety and efficacy based on the patients’ self-reporting of side effects and pain relief.
The company quotes John Breneman, MD, who is leading the next-phase investigation.
“For the last decade, radiation oncologists have been exploring Flash therapy as an important opportunity to create a paradigm shift in the way we treat patients,” says Breneman, who is medical director of the Cincinnati Children’s/UC Medical Center Proton Therapy Center. “The FAST-01 trial laid the groundwork for the approval of FAST-02, and we are excited to continue the clinical research and evaluate Flash therapy in a new patient cohort.”
According to the June 27 announcement, this center opened in 2016 and played a key role in the city of Cincinnati’s hosting of the world’s first clinical trial of Flash proton therapy.
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Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.