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NCT Number: NCT07671768

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

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.

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Key information

Conditions

Metastatic Malignant Solid Neoplasm Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Procedure

Undergo CT and/or PET/CT

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

MRI-guided Stereotactic Body Radiation Therapy

Radiation

Undergo MR-guided SBRT

Other names: Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy, MR-guided SBRT, MRI-guided SBRT

Positron Emission Tomography

Procedure

Undergo PET/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carol Felix

CONTACT

[email protected]

310-825-9771

Christy Palodichuk

CONTACT

[email protected]

1 310-794-2971

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • Viewray Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2036
Study completion
2038
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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