Proton Therapy Center to Lead Expanded Clinical Trial of Flash Treatment

Research By: John Breneman, MD

Post Date: June 29, 2022 | Publish Date:

The Flash clinical research underway at the Cincinnati Children’s/UC Health Proton Therapy Center, which involves an experimental treatment that delivers radiation therapy at ultra-high dose rates in typically less than 1 second, will advance as a result of the FDA granting an Investigational Device Exemption.

The FAST-02 clinical trial (FeAsibility Study of Flash therapy for the Treatment of Symptomatic Bone Metastases) is expected to enroll 10 patients with painful bone metastases. The study aims to evaluate treatment-related side effects and efficacy of treatment, which will be assessed by measuring trial participants’ pain relief.

The trial is sponsored by Varian Medical Systems, a provider of cancer care technologies and solutions. Varian announced FDA approval of the IDE in conjunction with the Cincinnati Children’s/UC Health Proton Therapy Center.

Approval of the FAST-02 study was supported by data from FAST-01, the first-ever human clinical trial of Flash.

Similar to FAST-01, FAST-02 will be conducted here by principal investigator John Breneman, MD, medical director of the Proton Therapy Center.

“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,” says Breneman. “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.”

The FAST-02 clinical trial will advance to indications of bone metastases in the chest, providing insights into the clinical use of Flash treatment for cancer metastases.

In connection with the FAST-02 clinical trial, the Varian ProBeam system’s proton particle accelerator has been modified to deliver Flash therapy. And Varian’s Eclipse treatment planning system will be modified to create plans for the Flash treatments.

The Cincinnati Children’s/UC Health Proton Therapy Center, which opened in 2016 on the Liberty Campus of Cincinnati Children’s, incorporates a $24 million, one-of-a-kind research facility. It includes a fully operational proton treatment room dedicated exclusively for research along with integrated laboratories.

The unique capabilities of the research center were instrumental in Cincinnati developing the world’s first clinical trial of Flash proton therapy. In addition, children and adults from around the world seek treatment for cancer in two clinical therapy rooms at the center.