Varian announced today that it received FDA investigational device exemption IDE to advance its Flash clinical research program.
Flash therapy, an experimental treatment modality, was designed to deliver radiation therapy at ultra-high dose rates in typically less than one second.
The Siemens Healthineers company will conduct the feasibility study of Flash therapy for the treatment of symptomatic bone metastases (FAST-02) with the IDE now secured, according to a news release.
“Receiving IDE approval for FAST-02 reaffirms our confidence in the potential of Flash therapy and represents an important step toward delivering this groundbreaking therapy in a clinical setting,” Varian VP of Flash Solutions Agam Sharda said in the release. “Together with our FlashForward Consortium, we have expanded Flash therapy research using our systems as we work to improve the patient experience. We look forward to continuing to collaborate with experts around the world to push the boundaries of innovation in cancer care.”
Data from the first human clinical trial of Flash, FAST-01, was used to support the approval of the FAST-02 study. Varian said that data will be reported later this year.
The FAST-02 trial was designed with input from scientific experts at the FlashForward Consortium. It will be conducted at the Cincinnati Children’s/UC Health Proton Therapy Center with Dr. John C. Breneman as principal investigator.
“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,” Breneman said. “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.”
FAST-02 will build on the clinical evidence from FAST-01 and will include bone metastases in the chest, providing critical insights into the clinical use of Flash treatment for cancer metastases. The company expects the trial to enroll 10 patients with painful thoracic bone metastases. It will evaluate treatment-related side effects and the efficacy of the treatment, which will be assessed using reported pain relief in trial participants.
In connection with the trial, Varian modified its Varian ProBeam system’s proton particle accelerator to deliver Flash therapy. It also modified the Varian Eclipse treatment planning system to create plans for Flash treatments.
“Preclinical research of Flash therapy indicates using ultra-high dose rates may be less toxic to patients overall and enhances sparing of adjacent healthy tissue,” Varian SVP and CMO Dr. Deepak “Dee” Khuntia said. “The FAST-02 study will advance our work toward an important proof of concept, particularly in deep-seated tumors. We are eager to build on our clinical understanding of Flash therapy as we continue our work to transform cancer care.”