Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Tumors, ONE SHOT Trial

June 23, 2026 updated by: Jonsson Comprehensive Cancer Center

ONE SHOT: Single-Fraction Adaptive MR-Guided Radiation Therapy for Metastatic Solid Tumors

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the incidence of acute grade ≥ 3 adverse events that are possibly, probably, or definitely related to single-fraction adaptive MR-guided SBRT.

SECONDARY OBJECTIVES:

I. To estimate local control (LC), progression-free survival (PFS) and overall survival (OS).

II. To characterize late grade ≥ 3 toxicity rates per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

III. To assess patient-reported health-related quality of life (HRQOL) using Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) at baseline, end of treatment, 3 months post-treatment, and 1 year post-treatment.

IV. To measure total in-room time, defined as the duration from patient entry to exit at the treatment console.

OUTLINE:

Patients undergo MR-guided SBRT over one treatment fraction on study. Patients also undergo magnetic resonance imaging (MRI) and computed tomography (CT) on study and CT or PET/CT throughout the study.

After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ann Raldow, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Histologically confirmed metastatic solid tumor (any primary site)
  • 1-3 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

Exclusion Criteria:

  • Uncontrolled infection or major comorbidity
  • Pregnant or breastfeeding
  • MRI contraindication
  • Life expectancy < 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (MR-guided SBRT)
Patients 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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: Computed Tomography
Undergo CT and/or PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Radiation: MRI-guided Stereotactic Body Radiation Therapy
Undergo MR-guided SBRT
Other Names:
  • MR-guided SBRT
  • Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy
  • MRI-guided SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicity rate
Time Frame: Up to 3 months post-radiation therapy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to local failure (Local control)
Time Frame: From end of study treatment to the presence of local or locoregional disease progression within the irradiated field, assessed up to 12 months
As assessed by imaging and clinical evaluation, according to Response Evaluation Criteria in Solid Tumors version 1.1. Will be estimated via Kaplan-Meier (KM) analysis. The median survival along with 95% confidence interval will also be reported.
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
Time Frame: 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
Will be estimated via KM analysis. The median survival along with 95% confidence interval will also be reported.
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
Time Frame: From end of study treatment to death from any cause, assessed up to 12 months
Will be estimated via KM analysis. The median survival along with 95% confidence interval will also be reported.
From end of study treatment to death from any cause, assessed up to 12 months
Incidence of late grade ≥ 3 toxicities
Time Frame: From 3 months post-radiation therapy up to 12 months post-radiation therapy
Assessed per CTCAE v5.0 for entire and sub-cohort, stratified by anatomic treatment site. Will be characterized via descriptive statistics.
From 3 months post-radiation therapy up to 12 months post-radiation therapy
PROMIS-29 patient-reported health-related quality-of-life (HRQOL)
Time Frame: Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment
Assessed using PROMIS-29 HRQOL questionnaires (Patient-Reported Outcomes Measurement Information System 29-item profile). Raw domain scores are converted to T-scores calibrated to the US general population, with a mean of 50 and standard deviation of 10. For symptom domains (anxiety, depression, fatigue, pain interference, sleep disturbance), higher scores indicate worse symptom burden. For functioning domains (physical function, social participation), higher scores indicate better functioning. Changes from baseline to 3 time points post-treatment will be analyzed.
Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment
Total in-room time
Time Frame: From patient entry to exit at the treatment console, approximately one day
The duration from patient entry to exit at the treatment console will be collected; summary statistics will be reported for entire cohort and sub-cohort of treated target number 1, 2 and 3, respectively.
From patient entry to exit at the treatment console, approximately one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Viewray Inc.

Investigators

  • Principal Investigator: Ann Raldow, MD, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2036

Study Completion (Estimated)

July 1, 2038

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-0235
  • NCI-2026-04081 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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