[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-metastasis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100584915","proton-sbrt-for-spinal-metastasis-100584915",false,"NCT06895564","Proton SBRT for Spinal Metastasis","A Pilot Study of Proton Stereotactic Body Radiotherapy for Spinal Metastasis","Inclusion Criteria:\n\n1. Histologic proof or unequivocal cytologic proof of nonhematologic malignancy. This may be obtained from either the primary or any metastatic site.\n2. Participants must have radiographic evidence of spinal metastasis on MRI.\n3. Participants must have a complex case that is unable to be effectively treated with photon SBRT, defined as inability to develop a photon SBRT plan that achieves adequate coverage (≥80% PTV coverage) with a prescription dose of 30 Gy in 5 fractions. Such cases include:\n\n   1. Extensive paraspinal disease\n   2. Reirradiation setting\n   3. Epidural extension (Bilsky grade ≥1c)\n4. Age ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky \\>60%).\n6. Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child.\n7. Patients must have the ability to understand and the willingness to sign a written informed consent document.\n8. All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines.\n\nExclusion Criteria:\n\n1. Participants may not have a spinal metastases case amenable to standard of care photon SBRT planning techniques that achieve ≥80% PTV coverage with a prescription dose of 30 Gy in 5 fractions.\n2. Patients who are unable to receive MRIs will be excluded from the study since MRIs will be critical in treatment planning.\n3. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a single-arm pilot study of proton stereotactic body radiotherapy (SBRT) for nonhematologic spinal metastasis in patients with complex lesions that are unable to be effectively treated with standard of care photon SBRT defined as inability to develop a photon SBRT plan that achieves adequate coverage (≥80% planning treatment volume (PTV) coverage)) with a prescription dose of 30 Gy in 5 fractions.",[26],"Spinal Metastasis",[28],"Proton SBRT","RECRUITING","2026-04-27",{"date":32,"type":33},"2026-04-29","ACTUAL",{"date":35,"type":33},"2025-04-22",{"date":37,"type":20},"2030-05",{"name":39,"class":40},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":41},"100585786","phase-1-a-phase-i-study-of-the-novottf-200m-and-novo-ttf-200a-systems-for-the-treatment-of-refractory-spinal-metastasis-100585786","NCT06906900","A Phase I Study of the NovoTTF-200M and Novo TTF-200A Systems for the Treatment of Refractory Spinal Metastasis","Inclusion Criteria:\n\n1. Patients with one or more spinal metastasis(es) affecting levels between C1 to S4 which have been previously treated with surgery and\u002For maximal doses radiation therapy to the spinal metastasis. For patients in the surgical group, patients must have completed maximal intralesional debulking of their tumor (within 90 days of enrollment).\n2. No more radiation options available for treatment to the spinal metastasis(es) that will undergo the TTF treatment\n3. Male or Female subjects aged ≥ 22 years.\n4. Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) must agree prior to study entry to use adequate contraception (e.g., hormonal, barrier device, or abstinence) for the duration of study participation.\n5. Patients must have a Karnofsky Performance Scale (KPS) (Appendix D) score of at least 70%.\n6. Patients must have the ability to independently disconnect the arrays or turn off the system if they feel uncomfortably hot while using the device.\n7. Patients (and\u002For legally authorized representative) should be able to fully understand the requirements of the trial, including the need to use the device for at least 18 hours per day, be willing to comply with all trial visits and assessments and be willing and able to sign an Institutional Review Board (IRB) approved written informed consent document (or provide assent where applicable).\n8. Patients with the following tumor histologies (numbers in parenthesis represent the frequencies\u002Fdevice patients with these histologies will be treated with):\n\n   1. Non-small cell lung cancer (150KHZ, TTF-200M)\n   2. Chordoma (150KHZ, TTF-200M)\n   3. Breast adenocarcinoma (150HKZ, TTF-200M)\n   4. Liver\u002Fgastrointestinal malignancy (150 KHZ, TTF-200M)\n   5. Endocrine origin carcinoma (150KHZ, TTF-200M)\n   6. Renal cell carcinoma (200KHZ, TTF-200A)\n   7. Prostate adenocarcinoma (200KHZ, TTF-200A)\n   8. Sarcoma (200KHZ, TTF-200A)\n9. For the non-surgical group only, expected survival of more than 8 months as confirmed by the primary oncologist.\n10. For the non-surgical group only, in case of multiple noncontiguous vertebral levels requiring treatment, all sites must be included under the largest length of the antero-posterior set of transducer arrays (25cm).\n11. Patients who have previously undergone surgery and already have spinal hardware implanted in the intended area of treatment may be enrolled in the surgical group, regardless of the timing of their original surgery.\n\nExclusion Criteria:\n\nPatients who meet any of the following exclusion criteria will not be eligible for the study:\n\n1. Psychiatric illness\u002Fsocial situations (homeless or living in a foreign country) that would limit compliance with study requirements.\n2. Physical or cognitive limitation that prevents the ability to independently disconnect the arrays or turn off the system if they feel uncomfortably hot while using the device. This includes patients that need a legally authorized representative for consent.\n3. Patients in the surgery group who have not fully recovered from the spinal surgery, where wound healing is compromised, requiring healing by second intention (i.e., the wound is left open and heals spontaneously).\n4. History of allergic reactions or sensitivity to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.\n5. Implanted pacemaker, defibrillator, nerve stimulator or other active electronic medical devices in the area of surgery or application of the skin transducers.\n6. Women who are pregnant or lactating.\n7. Prior surgery to the spinal level(s) to be treated with TTF is not an exclusion criterion.\n8. Enrollment on another clinical trial with investigational drugs\u002Fdevices is not an exclusion criterion and is kept at the discretion of the treating surgeon.\n9. Patients with leptomeningeal disease.\n10. Patients with severe pre-existing dermatological conditions (i.e., active herpes zoster, bullous pemphigoid reactions, Stevens-Johnson syndrome) that might interfere with interpretation of the device's skin toxicity.\n11. Patients receiving targeted therapy (i.e., EGFR inhibitors) who present with severe dermatological reactions at the site(s) to receive treatment with NovoTTF-200A or NovoTTF-200M. Prior treatment and complete resolution of a prior severe dermatological reaction are not exclusion criteria.\n12. Multiple noncontiguous progressive spine tumors separated by more than 25 cm.",{"count":49,"type":20},30,[51],"PHASE1","This clinical research study is to learn about the safety of the NovoTTF-200M and Novo TTF-200A Systems, when used either alone or in combination with standard therapy, in patients with tumors that did not respond to treatment.",[26],"2026-04-15",{"date":56,"type":33},"2026-04-20",{"date":58,"type":33},"2025-08-18",{"date":60,"type":20},"2029-02-17",{"name":62,"class":40},"M.D. Anderson Cancer Center",{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100573424","relieve-research-on-effectiveness-of-surgery-and-radiotherapy-on-relieving-spine-tumor-pain-in-patients-with-vertebral-metastases-100573424","NCT06746103","RELIEVE: Research on Effectiveness of Surgery and Radiotherapy on Relieving Spine Tumor Pain in Patients with Vertebral Metastases","RELIEVE Research on Effectiveness of Surgery and Radiotherapy on Relieving Spine Tumor Pain in Patients with Vertebral Metastases","RELIEVE","Inclusion Criteria:\n\n* Age 18 years and older\n* Patients diagnosed with metastatic spinal tumors with one index metastatic site that, confirmed by the treating clinicians, is causing spine pain\n* Patients experience at least one type of pain that is of interest of this study, namely, axial non-triggered pain, axial triggered\u002Fmechanical pain, radicular non-triggered pain, and radicular triggered\u002Fmechanical pain\n* At least one type of the pain experienced has an NRS \\> 4 of 10\n* Patients undergoing surgery and\u002For radiotherapy\n\n  * Surgery may be instrumented stabilization surgery alone, instrumented stabilization and decompression, or decompression surgery alone.\n  * Percutaneous screw fixation counts as instrumented stabilization surgery.\n  * Any kind of radiotherapy is includable.\n* Ability to provide informed consent according to the IRB\u002FEC defined and approved procedures\n\nExclusion Criteria:\n\n* Estimated survival \\\u003C 3 months\n* Patients with more than one symptomatic spine metastasis site\n\n  o An example is a patient with two metastasis sites: a lumbar metastasis (causing vertebral fracture and epidural compression leading to mechanical lower back pain and static radicular pain to legs) and a cervical metastasis (causing tumor-related pain at the neck).\n* Patients with other sources of pain that may confound the measurement of the primary outcome\n\n  o An example is a patient with liver metastasis which causes visceral pain that can confound the thoracic spinal pain caused by the spinal metastasis.\n* Patients undergoing the following treatments alone without the surgeries listed in the inclusion criteria or radiotherapy\n\n  * Cement augmentation, vertebroplasty, kyphoplasty, and other emerging interventions such as local ablative technique\n  * Chemotherapy or systemic therapy alone",{"count":72,"type":20},250,"OBSERVATIONAL","This is a prospective, multicenter, observational study focusing on assessing and managing pain in patients with metastatic spinal tumors. Pain from spinal metastases adversely impacts quality of life, function, and treatment outcomes. Advances in surgical techniques have shown significant benefits. However, previous studies either lacked nuanced differentiations or simply categorized pain as mechanical or non-mechanical; explaining the highly variable pain outcome measurements in these studies. This study employs the AO Spine Cancer-Related Pain Classification to better categorize neoplastic spinal pain by etiology.",[26],"NOT_YET_RECRUITING","2024-12-17",{"date":79,"type":33},"2024-12-24",{"date":81,"type":20},"2025-03-31",{"date":83,"type":20},"2027-11-30",{"name":85,"class":40},"AO Foundation, AO Spine"]