Varian has secured an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a clinical trial of FLASH therapy.

FLASH therapy is an experimental treatment modality designed to deliver radiation therapy at ultra-high dose rates.

With ultra-high dose rates, FLASH therapy is said to be delivered in less than one second and more than 100 times faster compared to conventional radiation therapy.

The study, which is named as FAST-01(feasibility study of FLASH radiotherapy for the treatment of symptomatic bone metastases), will include the investigational use of Varian’s ProBeam particle accelerator that is modified to deliver an advanced non-invasive treatment option for cancer patients.

Varian proton therapy solutions president and chief growth officer Kolleen Kennedy said: “Our progress in advancing FLASH therapy on the ProBeam platform¬†is a testament to Varian’s investments in research that improve care for patients with cancer and the importance of our collaboration with clinicians around the world through the FlashForward Consortium.”

Varian will recruit up to 10 patients with bone metastases in the FAST-01 feasibility study

Varian will enrol up to 10 patients with bone metastases in the FAST-01 feasibility study, which will assess clinical workflow feasibility, treatment-related side effects and efficacy of treatment as evaluated by measuring trial participants’ pain relief.

The company intends to recruit the first patient in the FAST-01 feasibility study by the end of this year.

Varian stated that it has led the concept of ultra-high dose rate radiation delivery, which has been studied for many years, to the clinical study stage.

The company has invested in bench and preclinical research and supported the 20-member group of institutions called FlashForward Consortium that includes experts in radiation oncology, translational sciences, and medical physics.

Varian chief medical officer and senior vice president Dr Deepak Dee Khuntia said: “Preclinical research of FLASH therapy indicates using ultra-high dose rates may be less toxic overall and enhance sparing of adjacent healthy tissue.

“The study is an important proof of concept, especially in deep-seated and not just superficial tumors, that adds to a growing body of data necessary to advance our understanding of how FLASH therapy works.”

In July 2019, Varian Medical Systems agreed to purchase drug-loadable microsphere and bland embolic bead product portfolio from Boston Scientific for around $90m (£71.3m).