Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation

Exclusion Criteria11

• Need for urgent surgical decompression or stabilization (e.g., acute/impending neurologic compromise, unstable pathologic fracture) that precludes percutaneous implantation at this time.
• Uncorrected coagulopathy or ongoing antithrombotic therapy that cannot be safely managed periprocedurally.
• Active systemic or local infection at/near the planned access route.
• Diffuse marrow replacement or extensive cortical destruction where percutaneous implantation is unsafe or unlikely to achieve local control without stabilization, per MDT judgment.
• Prior 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.
• Known hypersensitivity to materials/agents required for the procedure (e.g., contrast) not amenable to premedication or alternative imaging.
• Uncontrolled medical conditions posing prohibitive procedural risk (e.g., severe cardiopulmonary disease, uncontrolled hypertension/arrhythmia).
• Pregnant or breastfeeding.
• Inability to lie still or contraindications to required imaging/sedation not correctable.
• Concurrent participation in another interventional study that could confound efficacy/safety assessment at the treated site.
• Any condition that, in the investigator's judgment, would interfere with protocol adherence, safety monitoring, or outcome assessment.