[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastasis-spine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastasis-spine":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100538616","carbon-fiber-transpedicular-screws-in-treatment-of-spinal-metastatic-disease-100538616",false,"NCT06293157","Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease","Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease and Stereotactic Radiotherapy - a Prospective, Randomized Trial","CarboMetaspine","Inclusion Criteria:\n\n* Metastatic spinal disease,\n* ECOG quality of life of 0-2,\n* Eligibility for SBRT treatment,\n* Expected survival time \\>3 months,\n* Signed informed consent to participate in the study,\n* Sufficient organ capacity allowing to survive the perioperative period.\n\nExclusion Criteria:\n\n* Primary tumor of the spine,\n* Age \\\u003C18 years old,\n* Expected survival time \\\u003C3 months,\n* Eligibility for palliative radiotherapy,\n* No informed consent to participate in the study,\n* Pregnancy or breastfeeding,\n* The advancement of the disease preventing the technical use of implants.","ALL","18 Years",{"count":20,"type":21},226,"ESTIMATED","INTERVENTIONAL",[24],"NA","Background: Spinal metastatic disease constitute a serious clinical problem in oncology. Bones are the third most common organ where metastases are located, and the spine is the place where they are most often located. Due to the complexity of the clinical problem, metastatic spine disease remains of interest to many medical specialties: neurosurgery, orthopedics, clinical oncology, radiotherapy and rehabilitation. With the development of modern diagnostic methods and wider access to them, the demand for neurosurgical treatment in this group of patients is growing. Surgical treatment is undertaken in cases of spinal cord compression, instability, spinal deformation or pain that is resistant to radiotherapy. The standard treatment in most cases is posterior instrumentation of the spine using titanium pedicle screws. Unfortunately, these systems cause numerous artifacts in diagnostic imaging, both in CT and MRI. These distortions make it difficult to plan radiotherapy and determine the optimal dose that would avoid healthy tissues. Moreover, artifacts could make difficult postoperative follow-ups aimed at assessing local recurrence. The solution to these problems is the use of radiolucent implants. There are systems based on carbon fibers embedded in PEEK which do not cause typical artifacts for titanium implants.\n\nStudy plan: The open, three-arm, prospective randomized study is planned to involve 226 patients with metastatic disease of the spine, with a known or undiagnosed primary site. Patients will be qualified for 2 types of interventions. The first one includes treatment with stereotactic radiotherapy (SBRT) in the first stage of treatment and early instrumentation of the spine with titanium implants. The second type of intervention includes patients qualified for surgical treatment using spine stabilization and postoperative SBRT. Patients within this arm will be randomized into two groups differing in the type of material the instrumentation is made of: carbon-PEEK or titanium. The study group will be patients stabilized with carbon implants, and the control group will be those who will have titanium implants.\n\nStudy population: The study includes adult patients with metastatic spine disease, with a known or unknown primary tumor, qualified for SBRT and surgical treatment.\n\nAssumed effects: It is assumed that the treatment proposed in the project would extend progression free survival by several months or achieve local control in an additional 5% of patients. Moreover, by improving the quality of imaging, earlier diagnosis of local recurrences and implementation of appropriate locoregional treatment would be possible.",[27,28],"Metastatic Spinal Cord Compression","Metastasis Spine",[30,31,32,33],"metastatic spinal disease","stereotactic body radiotherapy","spinal cord compression","carbon fiber reinforced implants","RECRUITING","2025-12-08",{"date":37,"type":38},"2025-12-16","ACTUAL",{"date":40,"type":38},"2023-12-01",{"date":42,"type":21},"2033-12-31",{"name":44,"class":45},"Copernicus Memorial Hospital","OTHER",5,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100424108","dose-escalated-spine-sbrt-for-localized-metastasis-to-the-spinal-column-100424108","NCT04802603","Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column","Dose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column","DESSRT","Inclusion Criteria:\n\n* Zubrod Performance Status 0-2\n* Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)\n* Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion\n* Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis\n* For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months\n* Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)\n\nExclusion Criteria:\n\n* Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)\n* Non-ambulatory patients\n* \\>50% loss of vertebral body height or spinal instability to due pathologic compression fracture\n* Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord\n* Rapid neurologic decline\n* Patients for whom an MRI of the spine is medically contraindicated\n* Pregnant women",{"count":56,"type":21},60,[24],"This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques.\n\nIn standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.",[60,28],"Spine Metastases",[62,63],"Localized Metastasis","Spinal Column","2025-11-13",{"date":66,"type":38},"2025-11-14",{"date":68,"type":38},"2021-03-14",{"date":70,"type":21},"2029-12-31",{"name":72,"class":45},"Baptist Health South Florida",1]