Assessing Quality of Life and Outcomes for Cancer Patients Using RefleXion Radiotherapy
Official title: Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)
Run by RefleXion Medical · NCT05406167 · Data updated 2026-11-12
This study is trying to see how different types of radiotherapy affect the quality of life and treatment outcomes for about 750 cancer patients.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | RefleXion Medical Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 5 sites (Duarte, California and 4 other locations) |
| Status | Recruiting |
| Started | April 12, 2022 |
| Main results expected | April 25, 2026 |
| Study ends | April 25, 2026 |
| Registry record updated | August 15, 2025 |
| Trial ID | NCT05406167 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with local, locoregionally advanced, or metastatic malignancies who are indicated for radiotherapy.
✕Probably not a fit
Patients who are pregnant or have psychiatric or substance abuse disorders that interfere with study participation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the clinical outcomes and quality of life for patients undergoing radiotherapy using the RefleXion Medical Radiotherapy System. It will enroll approximately 750 patients diagnosed with local, locoregionally advanced, or metastatic malignancies, who will receive intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), or SCINTIX Biology-guided radiotherapy (BgRT). The study will analyze the severity of adverse effects, patient costs, and the workflow of radiotherapy planning, collecting dosimetric data throughout the treatment process.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of treatment outcomes and quality of life for cancer patients receiving advanced radiotherapy techniques.
How similar studies have gone: Other studies have shown success with similar radiotherapy approaches, indicating potential for meaningful advancements in treatment.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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: * 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
Where it's running
-
City Of Hope
Duarte, California, United States Recruiting -
Stanford Cancer Center
Palo Alto, California, United States Recruiting -
Yale University - Cancer Center
New Haven, Connecticut, United States Recruiting -
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States Recruiting -
UT Southwestern
Dallas, Texas, United States Recruiting
Study contacts
- Study coordinator: Debradenise S. Brooks
- Email: dbrooks@reflexion.com
- Phone: 6504828435
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
First human use of 177Lu‑AKIR001 for CD44v6‑positive advanced cancers
This trial tests a Lutetium‑177 radiolabeled drug (AKIR001) in adults with advanced, irresectable CD44v6‑expressing solid tumors who have no reasonable systemic treatment options.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.