Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Tumors, ONE SHOT Trial
ONE SHOT: Single-Fraction Adaptive MR-Guided Radiation Therapy for Metastatic Solid Tumors
2 other identifiers
interventional
25
1 country
1
Brief Summary
This clinical trial studies the side effects of magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) and to see how well it works in treating patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. The total dose of radiation is divided into smaller doses given over 1-5 days. This type of radiation therapy helps spare normal tissue. During MR-guided SBRT, MR imaging is used to define and localize the area to be treated and provide more accurate delivery. This allows the treatment to be given over one day. MR-guided SBRT may be safe, tolerable, and/or effective in treating patients with metastatic solid tumors. Tumors in the central nervous system will not be treated on this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2026
CompletedFirst Posted
Study publicly available on registry
June 26, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2038
June 26, 2026
June 1, 2026
10 years
June 16, 2026
June 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Acute toxicity rate
Defined as the percentage of patients who experience acute grade ≥ 3 adverse events relating to single-fraction adaptive magnetic resonance-guided stereotactic body radiation therapy. Will be calculated, along with the corresponding 95% Clopper-Pearson exact confidence interval. Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
Up to 3 months post-radiation therapy
Secondary Outcomes (6)
Time to local failure (Local control)
From end of study treatment to the presence of local or locoregional disease progression within the irradiated field, assessed up to 12 months
Progression-free survival
From end of study treatment to the first documented evidence of disease progression or death from any cause, whichever occurs first, assessed up to 12 months
Overall survival
From end of study treatment to death from any cause, assessed up to 12 months
Incidence of late grade ≥ 3 toxicities
From 3 months post-radiation therapy up to 12 months post-radiation therapy
PROMIS-29 patient-reported health-related quality-of-life (HRQOL)
Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment
- +1 more secondary outcomes
Study Arms (1)
Treatment (MR-guided SBRT)
EXPERIMENTALPatients undergo MR-guided SBRT over one treatment fraction on study. Patients also undergo MRI and CT on study and CT or PET/CT throughout the study.
Interventions
Undergo PET/CT
Undergo CT and/or PET/CT
Undergo MRI
Undergo MR-guided SBRT
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Histologically confirmed metastatic solid tumor (any primary site)
- metastases ≤ 5 cm each located outside the brain and spine
- Lesions treatable at 25-30 Gy × 1 fraction with MR guidance
- No overlapping prior radiation
- Absolute neutrophil count (ANC) \> 1.5 cell/mm\^3
- Hemoglobin (Hgb) \> 8.0 gm/dL
- Platelet (PLT) \> 150,000/mm\^3
- Total bilirubin \< or equal to 1.5 x upper limit of normal
- Aspartate aminotransferase (AST) \< or equal to three times upper limit of normal
- Alanine aminotransferase (ALT) \< or equal to three times upper limit of normal
- Informed consent obtained
You may not qualify if:
- Uncontrolled infection or major comorbidity
- Pregnant or breastfeeding
- MRI contraindication
- Life expectancy \< 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- Viewray Inc.collaborator
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Raldow, MD
UCLA / Jonsson Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2026
First Posted
June 26, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
July 1, 2036
Study Completion (Estimated)
July 1, 2038
Last Updated
June 26, 2026
Record last verified: 2026-06