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

Part of paid clinical trials in Duarte, California.

Sponsor
RefleXion Medical
Study ID
NCT05406167
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Registry - Observational — DEVICE
    Observation Registry for Medical Device

Study Details

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.

Key Dates

Start date
Apr 12, 2022
Status verified
Aug 2025
Primary completion
Apr 25, 2026
Completion
Apr 25, 2026

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Stereotactic Body Radiotherapy [SBRT]
    Patients treated with Reflexion X1 with SBRT as the standard of care
  • Arm: Intensity -Modulated Radiation Therapy [IMRT]
    Patients treated with Reflexion X1 with IMRT as the standard of care
  • Arm: Biology-guided Radiotherapy [BgRT]
    Patients treated with Reflexion X1 with BgRT as the standard of care

Primary Outcome Measure

Health Related Quality of Life (HRQOL) scores [ Time Frame: 30 Days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City Of HopeDuarteCalifornia91010
Arya Amini, MD (PRINCIPAL_INVESTIGATOR)
Stanford Cancer CenterPalo AltoCalifornia94305
Lucas K Vitzthum, MD (PRINCIPAL_INVESTIGATOR)
Yale University - Cancer CenterNew HavenConnecticut06510
Henry Park, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15219
Neal McCall, MD (PRINCIPAL_INVESTIGATOR)
UT SouthwesternDallasTexas75235
Tu Dan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City Of Hope· Duarte, CAStanford Cancer Center· Palo Alto, CAYale University - Cancer Center· New Haven, CTUniversity of Pittsburgh Medical Center· Pittsburgh, PAUT Southwestern· Dallas, TX

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