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

Trial ID or NCT#

NCT05406167

Status

recruiting iconRECRUITING

Purpose

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)

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Lucas Kas Vitzthum, MD
Lucas Kas Vitzthum, MD
Radiation oncologist
Clinical Associate Professor, Radiation Oncology - Radiation Therapy

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Contact

Team rad-onc
Rad-onc-ccto@lists.stanford.edu

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View on ClinicalTrials.gov