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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRefleXion Medical

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Registry - Observational

Treatment groups

500 Participants
are divided into 3 treatment groups

Sponsors and collaborators