Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| MRI-guided Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (MR-guided SBRT)
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
- Procedure: Magnetic Resonance Imaging
- Radiation: MRI-guided Stereotactic Body Radiation Therapy
- Procedure: Positron Emission Tomography
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Acute toxicity rate
- timeFrame
- Up to 3 months post-radiation therapy
- description
- 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 (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available