[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599871":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Minnesota","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiofrequency ablation and bone augmentation with radiotherapy","ACTIVE_COMPARATOR","Radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent to offer both tumor control and structural reinforcement. Radiotherapy (RT) uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size",[13],"Procedure: Radiofrequency ablation and bone augmentation with radiotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Radiotherapy alone","PLACEBO_COMPARATOR","ONLY uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size",[19],"Procedure: Radiotherapy alone",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","employs radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"High-energy radiation",[15],[30],{"name":31,"affiliation":5,"role":32},"Reza Talaie","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Surgery Clinical Trials Office","CONTACT","612-624-7463","surgCTO@umn.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Minneapolis","Minnesota","55455","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-93.26384,44.97997,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":25,"email":57},"Deb Mailand","612-626-2498","mailand@umn.edu",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100599871","radiofrequency-ablationbone-augmentation--radiotherapy-vs-radiotherapy-alone-100599871",false,"NCT07090122","Radiofrequency Ablation\u002FBone Augmentation + Radiotherapy vs Radiotherapy Alone","Inclusion Criteria:\n\n* Histologically confirmed metastatic T5-L5 disease of the spine (with up to two levels) as detected by any imaging study.\n* Have either associated bone pain or cross-sectional imaging characteristics that are predictors of SRE.\n* Age 18 years of age or older at the time of consent.\n* Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to study enrollment defined as:\n\n  1. absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n  2. platelets ≥ 50 × 109\u002FL\n  3. hemoglobin ≥ 10 g\u002FdL, independent of transfusion ≤14 days of screening\n  4. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN\n  5. total bilirubin ≤ 1.5 × ULN; \\\u003C 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome\n  6. serum albumin ≥ 30 g\u002FL (3.0 g\u002FdL)\n  7. serum creatinine ≤ 1.5 x ULN; OR estimated glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin using the Cockcroft Gault formula\n* Persons of childbearing potential (POCB) or with partners of childbearing potential must be willing to use contraception during study treatment and 6 months after study treatment.\n* Persons are considered to be of childbearing potential unless one or the following applies:\n\n  1. Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause\n  2. Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and\u002For bilateral oophorectomy\n* Voluntary written consent prior to the performance of any research related activity\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Clinical or radiologic evidence of epidural spinal cord compression or radicular pain.\n* Prior radiation therapy to the target lesion.\n* Candidates for spine stabilization surgery.\n* The target lesion(s) is deemed ineligible for RFA\u002FBA (e.g. unstable existing fractures\u002Fimpending fractures, involvement of the posterior elements, retropulsion, spinal canal narrowing, neuroforaminal narrowing, uncontrolled bleeding diathesis, active infection anywhere in the body, or purely blastic tumor). Note: Mixed lytic\u002Fblastic tumors are eligible.\n* The target lesion(s) size or location is beyond RFAs ability to safely perform, at the physician's discretion","ALL","18 Years",{"count":69,"type":70},36,"ESTIMATED","INTERVENTIONAL",[73],"NA","This is a single-center, randomized controlled pilot study of radiofrequency ablation and bone augmentation (RFA\u002FBA) plus radiotherapy (RT) vs. RT alone in patients with metastatic T5-L5 disease of the spine. Patients will be randomized 2:1 to receive either one treatment of RFA\u002FBA plus RT or RT to evaluate the occurrence of skeletal-related events. Skeletal-related events (SREs) are defined as new clinical or radiologic evidence of pathologic fracture, spinal cord or nerve root compression, pain or instability, and\u002For necessity for additional local intervention (i.e. surgery, repeat RFA\u002FBA or RT) due to persistent or progressive symptoms. Post-treatment follow-up for SREs are assessed at 1, 3, 6, 12, and 24 months.",[76,77],"Spine Metastases","Bone Pain",[79,80,81,82],"Radiofrequency ablation (RFA)","Bone augmentation (BA)","Radiotherapy (RT)","Metastatic disease of the spine","2025-12-01",{"date":85,"type":86},"2025-12-03","ACTUAL",{"date":83,"type":86},{"date":89,"type":70},"2028-06-13",{"name":5,"class":6},1]