With the IDE approval, the company is now allowed to study its investigational Flash treatment modality in the FAST-02 clinical trial, which builds on the clinical evidence from the previous FAST-01
Varian TrueBeam Linear Accelerator. (Credit: Michael Goodyear/Wikipedia)
Varian Medical Systems, a subsidiary of Siemens Healthineers, has received Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) to advance its Flash clinical research programme.
With the IDE approval, the company is now allowed to study its Flash therapy in the FAST-02 clinical trial, which builds on the clinical evidence from the previous FAST-01.
The FAST-01 was the first-ever human clinical trial to evaluate the Flash therapy, and its data supported the approval of the FAST-02 study, said Varian.
Flash therapy is an investigational treatment modality that rapidly delivers radiation therapy at ultra-high dose rates within a second, which is said to be faster than traditional radiation therapy.
Varian Flash Solutions vice president Agam Sharda said: “Receiving IDE approval for FAST-02 reaffirms our confidence in the potential of Flash therapy and represents an important step toward delivering this ground-breaking therapy in a clinical setting.”
Varian senior vice president and chief medical officer Deepak Khuntia said: “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.
“The FAST-02 study will advance our work toward an important proof of concept, particularly in deep-seated tumours. We are eager to build on our clinical understanding of Flash therapy as we continue our work to transform cancer care.”
The FAST-02 trial is designed to evaluate Flash therapy for bone metastases in the chest and provide critical insights into the clinical use of Flash treatment for cancer metastases.
The study will enrol 10 patients with painful thoracic bone metastases and aims to evaluate treatment-related side effects and the efficacy of the treatment.
Designed with support from scientific experts from the FlashForward Consortium, FAST-02 will be conducted at the Cincinnati Children’s/UC Health Proton Therapy Centre.
FAST-02 principal investigator John Breneman said: “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.
“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.”
Varian said that in connection with the FAST-02 clinical trial, the proton particle accelerator of its ProBeam system has been modified to deliver Flash therapy.
Also, its Eclipse treatment planning system has been modified to create plans for the Flash treatments, said the company.