NCT05406167Recruiting
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)
Source: ClinicalTrials.gov · Last updated 15 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 2 May 2022
- Start date
- 12 Apr 2022
- Primary completion date
- 25 Apr 2026
- Lead sponsor
- RefleXion Medical
- Diseases
- Childhood cancers
- NCT number
- NCT05406167
What you commit to
- Study type: Observational
- Planned participants: 500
- From 12 Apr 2022 to the primary completion date, 25 Apr 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- For BgRT patients only: Known allergy to FDG
Other
- Pregnant or expecting to conceive during the study.
- Inability to maintain immobilization, supine position for planning and treatments.
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Yale University - Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Stanford Cancer Center Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.