First patient enrolled in the PREMIER registry for all stages of cancer

The first patient has been enrolled in the PREMIER registry for patients at all stages of cancer.

The first patient has been enrolled in the University of Texas Southwestern Dallas PREMIER Registry for all-stage cancer patients, according to a press release from RefleXion Medical.

The PREMIER Registry is a prospective, evidence-based clinical outcomes registry developed to collect data to show the impact of the RefleXion XI Radiation Therapy System for patients with all types of solid tumors and lymphomas. The goals of the registry include the assessment of 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, in the press release. “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.”

A minimum of 750 patients from at least 4 sites across the United States will be enrolled in the prospective registry. Extensive baseline and follow-up data collected at the end of treatment will be included, as well as at months 3, 6, 9, 12, 18 and 24.

The registry aims to expand and include biology-guided radiation therapy (BgRT) procedures, a new radiation therapy treatment modality that uses signals detected by positron emission tomography (PET) to guide radiation therapy. BgRT aims to take the guesswork out of guiding radiation delivery using images taken days before treatment. As PET emissions guide treatment, the cancer itself acts as a rapid biological cue and continuously signals its location.

This treatment modality is the first to use the cancer itself to guide the delivery of radiation, including in moving tumors. The treatment aims to improve the permanent objective of managing the movement of these tumors, reducing margins and decreasing toxicity, so that several tumors can be treated at the same time and during the same session.

RefleXion X1 radiotherapy is currently capable of delivering stereotactic body radiotherapy, stereotactic radiosurgery and intensity modulated radiotherapy. BgRT has the potential to one day elevate the performance of PET tracers from a diagnostic tool to precise therapeutic direction and continues to be awaiting regulatory review.

Currently, RefleXion X1 radiation therapy is the only system designed with on-board PET detectors and the only machine capable of using the emissions to see and treat tumors. Additionally, this system is the first of its kind to incorporate a fast fan-beam KVCT.

“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,” added Sean Shirvani, MD, MPH, Chief Medical Officer of RefleXion, in the press. “We hope that collecting this rich repository of information before, during and after treatment will allow our clinical partners to investigate and identify the factors that best determine cancer outcomes, which could then provide patients with the information they need to make better decisions about their care.”

RefleXion announces a registry of real-world evidence outcomes to assess the impact of treatment at all stages of cancer. Press release. RefleXion Medical. May 3, 2022. Accessed May 5, 2022.

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