Siemens’ Varian Gains FDA IDE Nod for FAST-02 Trial

Varian (a Siemens Healthineers company) gained U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) to advance Varian’s Flash clinical research program with the FAST-02 (FeAsibility Study of Flash therapy for the Treatment of Symptomatic Bone Metastases) clinical trial.
 
The FAST-02 trial builds on clinical evidence from the FAST-01 human trial of Flash and will include bone metastases in the chest.
 
The trial aims to enroll 10 patients with painful thoracic bone metastases and evaluated treatment-related side effects and efficacy. Both metrics will be assessed using reported pain relief.
 
“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,” said John Breneman, Medical Director of the Cincinnati Children’s/UC Health Proton Therapy Center, University of Cincinnati Cancer Center member, told the press. “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.”
 
For the trial the Varian ProBeam system’s proton particle accelerator was modified to deliver Flash therapy, and the Varian Eclipse treatment planning tool was modified to create Flash treatment plans.
 
“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,” said Agam Sharda, VP of Flash Solutions at Varian. “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.”
 
“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,” said Deepak “Dee” Khuntia, M.D., senior VP and chief medical officer of Varian. “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.”