News|Proton Therapy| June 28, 2022

Varian Receives Investigational Device Exemption (IDE) for Flash Technology Clinical Trial, FAST-02

Flash therapy delivers radiation at ultra-high dose rates in typically less than one second and is capable of being over 100 times faster compared to conventional radiation therapy

June 27, 2022 —Varian, a Siemens Healthineers company, announced that theU.S. Food and Drug Administration (FDA)granted an 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. Data from FAST-01, the first-ever human clinical trial of Flash, was used to support the approval of the FAST-02 study and will be reported later this year.
The FAST-02 clinical trial builds on the clinical evidence from FAST-01 and will include bone metastases in the chest, providing critical insights into the clinical use ofFlash treatmentforcancer metastases.
FAST-02 is expected to enroll 10 patients with painful thoracic bone metastases and aims to evaluate treatment-related side effects and efficacy of treatment, which will be assessed using trial participants' reported pain relief.
Similar to FAST-01, FAST-02 was designed with input from leading scientific experts from the FlashForward Consortium and will be conducted at theCincinnati Children's/UC Health Proton Therapy CenterwithJohn C. Breneman, M.D., FASTRO, as principal investigator.
辛辛那提儿童/UC健康质子治疗中心医学主任、辛辛那提大学癌症中心成员Breneman说:“在过去的十年中，放射肿瘤学家一直在探索闪光疗法，将其作为一个重要的机会，来改变我们治疗患者的方式。”“FAST-01试验为FAST-02的批准奠定了基础，我们很高兴能继续进行临床研究，并在新的患者队列中评估Flash疗法。”
在FAST-02临床试验中，Varian ProBeam®系统的质子粒子加速器已被修改以提供Flash治疗，Varian的Eclipse™治疗计划系统也已修改以创建Flash治疗计划。瓦里安是唯一的行业合作伙伴，推动Flash治疗作为一个集成的端到端解决方案的发展，包括治疗计划、质量保证和治疗交付技术的创新。
"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, Vice President 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 Vice President 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."

About Flash Therapy

Flash therapy, an experimental treatment modality delivering radiation therapy at ultra-high dose rates in typically less than one second, may be over 100 times faster compared to conventional radiation therapy. The concept of ultra-high dose rate radiation delivery has been studied for many years. Dedicated research and development by the team at Varian has led the advancement of clinical evidence for proton Flash therapy. Varian's efforts include investing in bench and preclinical research and supporting the FlashForward™ Consortium, a group of dozens of institutions from around the world, which includes experts inradiation oncology, translational sciences and medical physics. 

For more information:www.varian.com