Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)
RefleXion Medical
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.
Description
This multi-center prospective registry is designed to assess the efficacy of IMRT, SBRT, and BgRT delivered via the RMRS. The study will seek to enroll approximately 750 patients initially and then remain open to further patients beyond at the discretion of the study sponsor and participating institutions. The number of IMRT, SBRT, and BgRT patients expected to enroll for the initial period is as follows: * N = 250 IMRT * N - 250 SBRT * N - 250 BgRT Patients diagnosed with local, locoregionally advanced, or metastatic malignancies will be treated with IMRT, SBRT, or BgRT using the RMRS, with…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceRegistry - Observational
Observation Registry for Medical Device
Locations (5)
- City Of HopeDuarte, California
- Stanford Cancer CenterPalo Alto, California
- Yale University - Cancer CenterNew Haven, Connecticut
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- UT SouthwesternDallas, Texas