Recruiting

RefleXion Radiotherapy

Sponsor:

RefleXion Medical

Code:

NCT05406167

Conditions

Cancer

Cancer Central Nervous System

Cancer Thoracic

Cancer, Gastrointestinal

Cancer Gynecologic

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Registry - Observational

Study Details

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 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

Study ID

NCT05406167

Start date

Apr 12, 2022

Status verified date

Aug, 2025

Completion date

Apr 25, 2026

Anticipated

Primary completion date

Apr 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Stereotactic Body Radiotherapy [SBRT]

Patients treated with Reflexion X1 with SBRT as the standard of care

Intensity -Modulated Radiation Therapy [IMRT]

Patients treated with Reflexion X1 with IMRT as the standard of care

Biology-guided Radiotherapy [BgRT]

Patients treated with Reflexion X1 with BgRT as the standard of care

Interventions

Registry - Observational

Observation Registry for Medical Device

Primary outcome measure

  • Health Related Quality of Life (HRQOL) scores [ Time Frame: 30 Days ]
  • Health Related Quality of Life (HRQOL) scores [ Time Frame: 90 Days ]

Central Contacts and Locations

Central contacts

Debradenise S. Brooks

6504828435dbrooks@reflexion.com

Mario Esquivel

mesquivel@reflexion.com

Locations

City Of Hope

Recruiting

Duarte, California, United States, 91010

Principal Investigator:

Arya Amini, MD

Stanford Cancer Center

Recruiting

Palo Alto, California, United States, 94305

Principal Investigator:

Lucas K Vitzthum, MD

Yale University - Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Principal Investigator:

Henry Park, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Principal Investigator:

Neal McCall, MD

UT Southwestern

Recruiting

Dallas, Texas, United States, 75235

Principal Investigator:

Tu Dan, MD

More Information

Sponsor

RefleXion Medical

Last update posted

Aug 15, 2025

Last verified

Aug, 2025

Keywords

  • IMRT
  • SBRT
  • Radiation Oncology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by RefleXion Medical on 2025-08-15.