RecruitingNCT05406167

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)

Sponsor

RefleXion Medical

Enrollment

500 participants

Start Date

Apr 12, 2022

Study Type

OBSERVATIONAL

Conditions

Cancer Cancer Head and Neck Cancer Central Nervous System Cancer Thoracic Cancer, Gastrointestinal Cancer Gynecologic Cancer, Genito-Urinary Cancers Lymphatic

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 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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is collecting data on patients who receive radiation therapy using a specific advanced machine (the RefleXion X1 system). Researchers want to track treatment outcomes and quality of life for people with various types of cancer being treated with this technology. **You may be eligible if...** - You have been diagnosed with cancer (local, regional, or spread to other parts of the body) - Your doctor has recommended radiation therapy using the RefleXion X1 machine - You are able to understand and sign a consent form - You are willing to take precautions against pregnancy during treatment (if applicable) **You may NOT be eligible if...** - You have another illness that makes radiation therapy unsafe - You are pregnant and unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERegistry - Observational

Observation Registry for Medical Device

Locations(5)

City Of Hope

Duarte, California, United States

Stanford Cancer Center

Palo Alto, California, United States

Yale University - Cancer Center

New Haven, Connecticut, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

UT Southwestern

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05406167

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