[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644542":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":56,"overallOfficials":120,"centralContacts":125,"locations":135,"responsibleParty":155,"collaborators":157,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":37,"eligibilityCriteria":167,"healthyVolunteers":163,"sex":168,"minAge":169,"maxAge":37,"enrollmentInfo":170,"targetDuration":37,"studyType":173,"phases":174,"briefSummary":175,"conditions":176,"keywords":37,"overallStatus":178,"whyStopped":37,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"Jonsson Comprehensive Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,22,25,29,33],{"measure":15,"description":16,"timeFrame":17},"Time to local failure (Local control)","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",{"measure":19,"description":20,"timeFrame":21},"Progression-free survival","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",{"measure":23,"description":20,"timeFrame":24},"Overall survival","From end of study treatment to death from any cause, assessed up to 12 months",{"measure":26,"description":27,"timeFrame":28},"Incidence of late grade ≥ 3 toxicities","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",{"measure":30,"description":31,"timeFrame":32},"PROMIS-29 patient-reported health-related quality-of-life (HRQOL)","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\u002FPeriprocedural, 3 months post-treatment, and 12 months post-treatment",{"measure":34,"description":35,"timeFrame":36},"Total in-room time","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",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"NA","SINGLE_GROUP","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","PRIMARY OBJECTIVE:\n\nI. To evaluate the incidence of acute grade ≥ 3 adverse events that are possibly, probably, or definitely related to single-fraction adaptive MR-guided SBRT.\n\nSECONDARY OBJECTIVES:\n\nI. To estimate local control (LC), progression-free survival (PFS) and overall survival (OS).\n\nII. To characterize late grade ≥ 3 toxicity rates per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.\n\nIII. 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.\n\nIV. To measure total in-room time, defined as the duration from patient entry to exit at the treatment console.\n\nOUTLINE:\n\nPatients 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\u002FCT throughout the study.\n\nAfter completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.",[46],{"label":47,"type":48,"description":49,"interventionNames":50},"Treatment (MR-guided SBRT)","EXPERIMENTAL","Patients undergo MR-guided SBRT over one treatment fraction on study. Patients also undergo MRI and CT on study and CT or PET\u002FCT throughout the study.",[51,52,53,54,55],"Procedure: Computed Tomography","Procedure: Magnetic Resonance Imaging","Radiation: MRI-guided Stereotactic Body Radiation Therapy","Procedure: Positron Emission Tomography","Other: Questionnaire Administration",[57,75,95,104,116],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"PROCEDURE","Computed Tomography","Undergo CT and\u002For PET\u002FCT",[47],[63,64,65,66,67,68,69,70,71,72,73,74],"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",{"type":58,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Magnetic Resonance Imaging","Undergo MRI",[47],[80,81,82,83,84,85,86,87,88,89,90,91,92,93,94],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":100},"RADIATION","MRI-guided Stereotactic Body Radiation Therapy","Undergo MR-guided SBRT",[47],[101,102,103],"Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy","MR-guided SBRT","MRI-guided SBRT",{"type":58,"name":105,"description":106,"armGroupLabels":107,"otherNames":108},"Positron Emission Tomography","Undergo PET\u002FCT",[47],[109,110,111,112,113,114,115],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":6,"name":117,"description":118,"armGroupLabels":119,"otherNames":37},"Questionnaire Administration","Ancillary studies",[47],[121],{"name":122,"affiliation":123,"role":124},"Ann Raldow, MD","UCLA \u002F Jonsson Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[126,131],{"name":127,"role":128,"phone":129,"phoneExt":37,"email":130},"Carol Felix","CONTACT","310-825-9771","cfelix@mednet.ucla.edu",{"name":132,"role":128,"phone":133,"phoneExt":37,"email":134},"Christy Palodichuk","1 310-794-2971","cpalodichuk@mednet.ucla.edu",[136],{"facility":123,"status":37,"city":137,"state":138,"zip":139,"country":140,"countryCode":141,"cosmosGeoPoint":142,"geoPoint":147,"contacts":148},"Los Angeles","California","90095","United States","US",{"type":143,"coordinates":144},"Point",[145,146],-118.24368,34.05223,{"lat":146,"lon":145},[149,151,154],{"name":132,"role":128,"phone":150,"phoneExt":37,"email":134},"310-794-2971",{"name":152,"role":128,"phone":153,"phoneExt":37,"email":130},"Care Felix","+1 310-825-9771",{"name":122,"role":124,"phone":37,"phoneExt":37,"email":37},{"type":156,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[158],{"name":159,"class":160},"Viewray Inc.","INDUSTRY","100644542","magnetic-resonance-guided-stereotactic-body-radiation-therapy-for-the-treatment-of-metastatic-solid-tumors-one-shot-trial-100644542",false,"NCT07671768","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","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n* Histologically confirmed metastatic solid tumor (any primary site)\n* 1-3 metastases ≤ 5 cm each located outside the brain and spine\n* Lesions treatable at 25-30 Gy × 1 fraction with MR guidance\n* No overlapping prior radiation\n* Absolute neutrophil count (ANC) \\> 1.5 cell\u002Fmm\\^3\n* Hemoglobin (Hgb) \\> 8.0 gm\u002FdL\n* Platelet (PLT) \\> 150,000\u002Fmm\\^3\n* Total bilirubin \\\u003C or equal to 1.5 x upper limit of normal\n* Aspartate aminotransferase (AST) \\\u003C or equal to three times upper limit of normal\n* Alanine aminotransferase (ALT) \\\u003C or equal to three times upper limit of normal\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Uncontrolled infection or major comorbidity\n* Pregnant or breastfeeding\n* MRI contraindication\n* Life expectancy \\\u003C 3 months","ALL","18 Years",{"count":171,"type":172},25,"ESTIMATED","INTERVENTIONAL",[39],"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\u002For effective in treating patients with metastatic solid tumors. Tumors in the central nervous system will not be treated on this study.",[177],"Metastatic Malignant Solid Neoplasm","NOT_YET_RECRUITING","2026-08-20",{"date":181,"type":182},"2026-08-24","ACTUAL",{"date":184,"type":172},"2026-12-01",{"date":186,"type":172},"2038-12-01",{"name":5,"class":6},1]