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

NCT05406167 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-08-15

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Registry - Observational

Observation Registry for Medical Device

Sponsors & Collaborators

  • RefleXion Medical

    lead INDUSTRY

Principal Investigators

  • Sean Shirvani, MD · RefleXion Medical

  • Karine Feghali, MD · RefleXion Medical

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2026-04-25
Completion
2026-04-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406167 on ClinicalTrials.gov