[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606164":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":60,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Jinan Military General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental - TPS + Biomechanical Dual-Simulation","EXPERIMENTAL","Single-group assignment using the dual-simulation planning workflow integrating TPS with patient-specific finite element modeling to optimize dose distribution and mechanical safety (fracture risk, needle stability, seed migration). Image-guided implantation is performed per optimized plan; postoperative CT provides dosimetric verification. Outcomes include pain response, dosimetry, biomechanics-related events, and safety.",[13],"Other: Dual-Simulation TPS + Biomechanical Planning",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator - Conventional TPS","ACTIVE_COMPARATOR","Preoperative planning using conventional TPS per institutional standards to meet dosimetric goals and OAR constraints; no biomechanical modeling. Image-guided implantation per plan; postoperative CT for seed localization and dosimetric verification. Follow-up schedule identical to the",[19],"Other: Conventional TPS Planning",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Dual-Simulation TPS + Biomechanical Planning","Combines TG-43-based TPS with a patient-specific FE biomechanical model to optimize needle paths and seed placement considering OAR limits, fracture risk, needle stability, and seed migration risk.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Conventional TPS Planning","Conventional TPS-driven plan per institutional practice; no biomechanical modeling.",[15],[31],{"name":32,"affiliation":25,"role":33},"min 李 li","STUDY_DIRECTOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"min li, dr","CONTACT","0531-51665482","924787237@qq.com",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":42},"min li","liminyingxiang@163.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The 960 Hospital of the People's Liberation Army of China","RECRUITING","Jinan","Shandong","250031","China","CN",{"type":53,"coordinates":54},"Point",[55,56],116.99722,36.66833,{"lat":56,"lon":55},[59],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Li Min","Vice Director","100606164","research-on-the-optimization-of-treatment-for-spinal-metastases-with-radioactive-particle-implantation-using-tps-and-mechanical-dual-simulation-100606164",false,"NCT07171996","Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation","Inclusion Criteria:\n\n* Age ≥18 years.\n\nRadiologically or histologically confirmed bone metastasis with a lesion suitable for percutaneous radioactive seed implantation (e.g., I-125), per multidisciplinary assessment.\n\nIndication for local palliation\u002Fcontrol: moderate-to-severe pain at lesion (e.g., BPI\u002FVAS ≥4) and\u002For imaging evidence of progression or high-risk features warranting local therapy.\n\nMeasurable\u002Fevaluable target lesion on CT\u002FMRI; target location accessible for needle placement per institutional practice.\n\nECOG performance status 0-2.\n\nEstimated life expectancy ≥3 months.\n\nAdequate hemostasis: platelets ≥80×10\\^9\u002FL, INR ≤1.5 (or per protocol), and able to hold\u002Fbridge anticoagulation as clinically indicated.\n\nAdequate organ function to undergo the procedure and anesthesia\u002Fsedation per site standards.\n\nAble to undergo required imaging (CT; MRI if applicable).\n\nWilling and able to provide written informed consent and comply with follow-up.\n\nFor women of childbearing potential and men with partners of childbearing potential: agreement to use effective contraception during and for the protocol-defined period after implantation.\n\nExclusion Criteria:\n\n* Need for urgent surgical decompression or stabilization (e.g., acute\u002Fimpending neurologic compromise, unstable pathologic fracture) that precludes percutaneous implantation at this time.\n\nUncorrected coagulopathy or ongoing antithrombotic therapy that cannot be safely managed periprocedurally.\n\nActive systemic or local infection at\u002Fnear the planned access route.\n\nDiffuse marrow replacement or extensive cortical destruction where percutaneous implantation is unsafe or unlikely to achieve local control without stabilization, per MDT judgment.\n\nPrior radiation or surgery to the index lesion that, in the investigator's opinion, makes additional seed implantation unsafe or non-beneficial; postoperative bed without a discrete target for seed placement.\n\nKnown hypersensitivity to materials\u002Fagents required for the procedure (e.g., contrast) not amenable to premedication or alternative imaging.\n\nUncontrolled medical conditions posing prohibitive procedural risk (e.g., severe cardiopulmonary disease, uncontrolled hypertension\u002Farrhythmia).\n\nPregnant or breastfeeding.\n\nInability to lie still or contraindications to required imaging\u002Fsedation not correctable.\n\nConcurrent participation in another interventional study that could confound efficacy\u002Fsafety assessment at the treated site.\n\nAny condition that, in the investigator's judgment, would interfere with protocol adherence, safety monitoring, or outcome assessment.","ALL","18 Years","55 Years",{"count":74,"type":75},150,"ESTIMATED","INTERVENTIONAL",[78],"NA","This prospective, open-label randomized trial evaluates a dual-simulation planning strategy that combines standard brachytherapy TPS with patient-specific biomechanical modeling for radioactive seed implantation in bone metastases. The approach aims to improve dose coverage while accounting for fracture risk, needle path stability, and seed migration. Eligible patients with painful and\u002For progressive bone metastases are randomized to dual-simulation planning versus conventional TPS. All undergo image-guided implantation with post-implant dosimetric verification and standardized follow-up. The primary endpoint is 3-month pain response (BPI\u002FVAS, adjusted for analgesic use). Secondary endpoints include dosimetry (D90, V100, CI, HI), local control\u002Fprogression, seed migration, skeletal-related events and fractures, SINS and functional status, quality of life, procedure-related complications (CTCAE v5.0), and procedure metrics. We hypothesize the dual-simulation strategy will enhance dosimetric quality and reduce biomechanics-related complications, improving pain and function.",[81],"Bone Metastases in Subjects With Advanced Cancer",[83,84,85],"tps","dynamics","osseous metastasis","2025-09-11",{"date":88,"type":89},"2025-09-15","ACTUAL",{"date":91,"type":89},"2025-07-01",{"date":93,"type":75},"2027-06-01",{"name":62,"class":6},1]