RefleXion Medical Radiotherapy System for Various Cancers

This study is observing patients receiving radiation therapy using the RefleXion Medical Radiotherapy System (RMRS) for different types of cancer, including those in the central nervous system, chest, stomach/intestines, and female reproductive organs. The RMRS can deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), or SCINTIX Biology-guided radiotherapy (BgRT). Researchers want to understand how this system affects your quality of life and any side effects you might experience. They will also look at the costs involved. The study aims to enroll about 750 patients initially, and then potentially more, who are already scheduled to receive radiation therapy with the RMRS. Your quality of life will be assessed at 30 and 90 days after treatment.

Study design
This is an observational study that plans to enroll about 750 patients initially, with the possibility of more later. It is designed to observe patients receiving standard radiation therapy using the RefleXion Medical Radiotherapy System.
What's involved
You would need to be willing to sign an informed consent form. Your quality of life will be assessed at 30 and 90 days after your radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
Your health-related quality of life will be measured at 30 days and 90 days after treatment.

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NCT05406167

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

Recruiting
Not specifiedAll AgesObservational
RefleXion Medical
~500 participants
Updated 2025-08-15 on ClinicalTrials.gov
What's tested:Registry - Observational

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Health Related Quality of Life (HRQOL) scores
Measured over 30 Days
+1 more outcome measured
Cancer
Cancer Central Nervous System
Cancer Thoracic
Cancer, Gastrointestinal
Cancer Gynecologic
Cancer, Genito-Urinary
Cancers Lymphatic
Cancer Head and Neck
5 sites across 4 states
California2
Connecticut1
Pennsylvania1
Texas1
  • Sean Shirvani, MD · STUDY_DIRECTOR · RefleXion Medical
  • Karine Feghali, MD · STUDY_DIRECTOR · RefleXion Medical

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Eligibility criteria

Inclusion

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

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
  • Health Related Quality of Life (HRQOL) scores30 Days

    Evaluate patient-reported quality of life after IMRT, SBRT, or BgRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30. The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.

  • Health Related Quality of Life (HRQOL) scores90 Days

    Evaluate patient-reported quality of life after IMRT or SBRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30. The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.