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Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System

Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)

Who can join

All ages · All sexes

Inclusion Criteria:

* Able to comprehend and be willing to sign an informed consent form (ICF).
* Diagnosis of local, loco-regionally advanced, or metastatic malignancy for whom radiotherapy is indicated
* Radiotherapy to be delivered on the RMRS X1 with IMRT, SBRT, or BgRT technique.
* Absence of concurrent illness that deems radiotherapy a contraindication which will be determined by the treating radiation oncologist.
* Female and male patients of child-bearing potential willing to take appropriate precautions to avoid pregnancy while being treated. Permitted methods in preventing pregnancy should be communicated to the patient and their understanding confirmed by the treating Physician.
* For BgRT patients only: Deemed eligible for BgRT with FDG per BgRT planning session

Exclusion Criteria:

* Pregnant or expecting to conceive during the study.
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with study requirements and follow-up visits.
* Inability to maintain immobilization, supine position for planning and treatments.
* For BgRT patients only: Known allergy to FDG

About the study

The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), or SCINTIX Biology-guided radiotherapy (BgRT) in standard of care (SOC) use in the treatment of local,loco-regionally advanced, and oligometastatic malignancies. In addition, patient costs and charges will be analyzed to quantify the health economic impact of this modality. Workflow and quality of radiotherapy planning including a collection of dosimetric data will also be analyzed.

What is being tested

• Registry - Observational (device)

Sponsor: RefleXion Medical · Participants: 500 · Started: Apr 12, 2022

Contact the study team

• Debradenise S. Brooks · Phone: 6504828435

Official record on ClinicalTrials.gov — NCT05406167

Locations in the U.S.

Conditions

• Cancer (all types)
• Brain and Spinal Cord Tumors
• Gastrointestinal Cancers
• Urogenital Cancer
• Head and Neck Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.