The first patient has been enrolled into the PREMIER registry for patients with all stages of cancer.
The first patient has been enrolled into the PREMIER registry at the University of Texas Southwestern in Dallas for patients with all stages of cancer, according to a press release from RefleXion Medical.
The PREMIER registry is a prospective, real-world evidence clinical outcomes registry developed to collect data in order to show the impact of the RefleXion XI radiotherapy system for patients with all solid tumor types and lymphoma cancers. Goals of the registry include assessing health-related quality of life, acute and long-term side effects in patients, and cancer-related outcomes.
"We believe that adapting radiotherapy plans based on how the tumor responds to the first radiation dose will be a key component in bringing together radiotherapy with drug therapies, such as targeted and immune-oncology agents," stated 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 endpoints in prospective registries, such as RefleXion’s PREMIER registry, are imperative."
A minimum of 750 patients from at least 4 sites across the United States will be enrolled within 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 procedures of biology-guided radiotherapy (BgRT), a new radiotherapy treatment modality that uses signals detected from positron emission tomography (PET) to guide radiotherapy. BgRT aims to take away uncertainty of guiding radiation delivery using images taken days before treatment. As PET emissions guide treatment, the cancer itself acts as a fast, and biological fiducial signals its location continuously.
This treatment modality is the first to utilize the cancer itself to guide radiation delivery, including within moving tumors. The treatment aims to improve the ongoing goal of managing motion of these tumors, reducing margins, and diminishing toxicity, so multiple tumors can be treated at the same time and during the same session.
RefleXion X1 radiotherapy is currently able to deliver 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 guidance and continues to be pending regulatory review.
Currently, RefleXion X1 radiotherapy is the only system designed with onboard PET detectors and the only machine capable of using emissions to see and treat tumors. Further, this system is the first of its kind to have onboard fast fan-beam KVCT.
“Our prospective registry will capture and organize an unprecedented level of data including patient, demographic, tumor, biomarker, imaging and treatment information for all stages of cancer," added Sean Shirvani, MD, MPH, chief medical officer at RefleXion, in the press release. "Our hope is that collecting this rich repository of information before, during, and after treatment will enable our clinical partners to investigate and identify the factors that best determine cancer outcomes, which may then arm patients with the information they need to make better decisions around their care."