Clinical trial Recruiting at 5 sites Observational

Assessing Quality of Life and Outcomes for Cancer Patients Using RefleXion Radiotherapy

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

Run by RefleXion Medical · NCT05406167 · Data updated 2026-11-12

This study is trying to see how different types of radiotherapy affect the quality of life and treatment outcomes for about 750 cancer patients.

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Quick facts

Study typeObservational
SexAll
Enrollment500 (estimated)
SponsorRefleXion Medical
Industry-sponsored
Drugs / interventionsradiation
Locations5 sites (Duarte, California and 4 other locations)
StatusRecruiting
StartedApril 12, 2022
Main results expectedApril 25, 2026
Study endsApril 25, 2026
Registry record updatedAugust 15, 2025
Trial IDNCT05406167 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients diagnosed with local, locoregionally advanced, or metastatic malignancies who are indicated for radiotherapy.

Probably not a fit

Patients who are pregnant or have psychiatric or substance abuse disorders that interfere with study participation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the clinical outcomes and quality of life for patients undergoing radiotherapy using the RefleXion Medical Radiotherapy System. It will enroll approximately 750 patients diagnosed with local, locoregionally advanced, or metastatic malignancies, who will receive intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), or SCINTIX Biology-guided radiotherapy (BgRT). The study will analyze the severity of adverse effects, patient costs, and the workflow of radiotherapy planning, collecting dosimetric data throughout the treatment process.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of treatment outcomes and quality of life for cancer patients receiving advanced radiotherapy techniques.

How similar studies have gone: Other studies have shown success with similar radiotherapy approaches, indicating potential for meaningful advancements in treatment.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • City Of Hope
    Duarte, California, United States
    Recruiting
  • Stanford Cancer Center
    Palo Alto, California, United States
    Recruiting
  • Yale University - Cancer Center
    New Haven, Connecticut, United States
    Recruiting
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • UT Southwestern
    Dallas, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.