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Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation
Sponsor: Li Min
Summary
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/or 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/VAS, adjusted for analgesic use). Secondary endpoints include dosimetry (D90, V100, CI, HI), local control/progression, 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.
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-07-01
Completion Date
2027-06-01
Last Updated
2025-09-15
Healthy Volunteers
No
Interventions
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.
Conventional TPS Planning
Conventional TPS-driven plan per institutional practice; no biomechanical modeling.
Locations (1)
The 960 Hospital of the People's Liberation Army of China
Jinan, Shandong, China