RefleXion Announces Registry of Real-World Evidence Findings to Assess Treatment Impact in All Stages of Cancer

May 4, 2022 – RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiation therapy (BgRT) for all stages of cancer, announced the enrollment of the first patient in its PREMIER registry, a registry Prospective Clinical Outcomes Registry for cancer patients at all stages at the University of Texas (UT) Southwestern in Dallas.

The PREMIER Registry was created to collect data to demonstrate the impact of the RefleXion X1 Radiation Therapy System, the first-ever system with embedded fast fan-beam KVCT, on patients with all types of solid tumors and lymphomas . The registry will expand to include BgRT procedures, a new radiation therapy treatment modality that uses signals detected by positron emission tomography (PET) to guide radiation therapy. The X1 is the first and only system designed with embedded PET detectors. The PREMIER registry will assess health-related quality of life, acute and long-term side effects in patients, and cancer-related outcomes.

“We believe that tailoring radiation therapy plans based on the tumor’s response to the first dose of radiation will be a key element in combining radiation therapy with drug therapies, such as targeted and immuno-oncology agents,” said Tu Dan, MD, assistant professor in the department of radiation oncology at UT Southwestern Medical Center. “However, to fully understand the utility of this approach, robust and accurate data collected through longitudinal parameters in prospective registries, such as RefleXion’s PREMIER registry, is imperative.”

The PREMIER registry will include extensive baseline data as well as follow-up data collected at the end of treatment and then again at three, six, nine, 12, 18 and 24 months. The registry will enroll a minimum of 750 patients from a minimum of four sites across the United States.

“Our forward-looking registry will capture and organize an unprecedented level of data, including patient information, demographics, tumors, biomarkers, imaging and treatment for all stages of cancer,” said Sean Shirvani, MD, MPH, Chief Medical Officer at RefleXion. “Our hope is that collecting this rich repository of information before, during and after treatment will allow our clinical partners to study and identify the factors that best determine cancer outcomes, which could then provide patients the information they need to make better decisions about their care.

Prospective registries define specific information and characteristics in advance, before data collection or the impacts of a treatment are known, including the monitoring interval for patient follow-up. Known as longitudinal data over time, it improves data accuracy because it minimizes reliance on patient recall. Therefore, prospective registries can establish stronger associations between the treatment given and a patient’s outcome.

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