Actively Recruiting
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
Led by RefleXion Medical · Updated on 2025-08-15
500
Participants Needed
5
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 as determined by the treating radiation oncologist
- Female and male patients of child-bearing potential willing to take precautions to avoid pregnancy during treatment
- For BgRT patients only: Eligible for BgRT with FDG per BgRT planning session
You will not qualify if you...
- Pregnant or expecting to conceive during the study
- Known psychiatric or substance abuse disorder interfering with ability to cooperate with study requirements and follow-up
- Inability to maintain immobilization or supine position for planning and treatment
- For BgRT patients only: Known allergy to FDG
AI-Screening
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Trial Site Locations
Total: 5 locations
1
City Of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Stanford Cancer Center
Palo Alto, California, United States, 94305
Actively Recruiting
3
Yale University - Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
5
UT Southwestern
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
D
Debradenise S. Brooks
CONTACT
M
Mario Esquivel
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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