RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-04-12
Study Completion:2026-04-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05406167

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to comprehend and be willing to sign an informed consent form (ICF).
  2. * Diagnosis of local, loco-regionally advanced, or metastatic malignancy for whom radiotherapy is indicated
  3. * Radiotherapy to be delivered on the RMRS X1 with IMRT, SBRT, or BgRT technique.
  4. * Absence of concurrent illness that deems radiotherapy a contraindication which will be determined by the treating radiation oncologist.
  5. * 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.
  6. * For BgRT patients only: Deemed eligible for BgRT with FDG per BgRT planning session
  1. * Pregnant or expecting to conceive during the study.
  2. * 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.
  3. * Inability to maintain immobilization, supine position for planning and treatments.
  4. * For BgRT patients only: Known allergy to FDG

Contacts and Locations

Study Contact

Debradenise S. Brooks
CONTACT
6504828435
dbrooks@reflexion.com
Mario Esquivel
CONTACT
mesquivel@reflexion.com

Principal Investigator

Sean Shirvani, MD
STUDY_DIRECTOR
RefleXion Medical
Karine Feghali, MD
STUDY_DIRECTOR
RefleXion Medical

Study Locations (Sites)

City Of Hope
Duarte, California, 91010
United States
Stanford Cancer Center
Palo Alto, California, 94305
United States
Yale University - Cancer Center
New Haven, Connecticut, 06510
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
United States
UT Southwestern
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: RefleXion Medical

  • Sean Shirvani, MD, STUDY_DIRECTOR, RefleXion Medical
  • Karine Feghali, MD, STUDY_DIRECTOR, RefleXion Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-12
Study Completion Date2026-04-25

Study Record Updates

Study Start Date2022-04-12
Study Completion Date2026-04-25

Terms related to this study

Keywords Provided by Researchers

  • IMRT
  • SBRT
  • Radiation Oncology

Additional Relevant MeSH Terms

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