Status:
RECRUITING
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
Lead Sponsor:
RefleXion Medical
Conditions:
Cancer
Cancer Central Nervous System
Eligibility:
All Genders
Brief Summary
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 inte...
Detailed Description
This multi-center prospective registry is designed to assess the efficacy of IMRT, SBRT, and BgRT delivered via the RMRS. The study will seek to enroll approximately 750 patients initially and then re...
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
Key Trial Info
Start Date :
April 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 25 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05406167
Start Date
April 12 2022
End Date
April 25 2026
Last Update
August 15 2025
Active Locations (5)
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1
City Of Hope
Duarte, California, United States, 91010
2
Stanford Cancer Center
Palo Alto, California, United States, 94305
3
Yale University - Cancer Center
New Haven, Connecticut, United States, 06510
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219