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.
Age ≥18 years.
Need for urgent surgical decompression or stabilization (e.g., acute/impending neurologic compromise, unstable pathologic fracture) that precludes percutaneous implantation at this time.
Parallel
Dual-Simulation TPS + Biomechanical Planning
Other interventionCombines 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
Other interventionConventional TPS-driven plan per institutional practice; no biomechanical modeling.
Pain Response at 3 Months
Proportion of participants achieving pain response at the treated site 3 months post-implant, defined as ≥2-point absolute reduction or ≥30% relative reduction from baseline in worst pain (BPI-SF item 3 or 0-10 VAS), without an increase in analgesic consumption; if analgesic use changes, response is adjudicated using standardized analgesic-adjusted criteria (e.g., IMMPACT-consistent rules with oral morphine equivalent dose). Pain is collected by trained staff blinded to allocation; centralized, de-identified adjudication applies. Primary analysis compares proportions between arms (risk difference and 95% CI; two-sided α=0.05). Time Frame: Baseline and 3 months post-implant.
Local Tumor Control (Treated Site)
Proportion of participants without local progression at the treated lesion, assessed by centralized imaging review. Local progression is defined as any of: (a) ≥20% increase in maximal diameter or volumetric expansion on CT/MRI with an absolute increase of ≥5 mm; (b) new nodular enhancement or soft-tissue extension contiguous with the treated site; (c) unequivocal progression by MD Anderson bone response criteria; or (d) metabolic progression on PET-CT per PERCIST when available. Death without prior local progression is counted as failure in sensitivity analyses; primary analysis censors at last evaluable imaging. Results reported as local control rate and Kaplan-Meier estimates of time to local progression with 95% CIs. Imaging is reviewed by blinded independent radiologists/physicists
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Li Min
Lead sponsor
Jinan Military General Hospital
Sponsor institution
