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

Description

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

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Study Overview

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Study Details

Study overview

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.

Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)

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

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Duarte

City Of Hope, Duarte, California, United States, 91010

Palo Alto

Stanford Cancer Center, Palo Alto, California, United States, 94305

New Haven

Yale University - Cancer Center, New Haven, Connecticut, United States, 06510

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15219

Dallas

UT Southwestern, Dallas, Texas, United States, 75235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

RefleXion Medical,

Sean Shirvani, MD, STUDY_DIRECTOR, RefleXion Medical

Karine Feghali, MD, STUDY_DIRECTOR, RefleXion Medical

Study Record Dates

2026-04-25