NCT07171996

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Li Min · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aims to evaluate a "dual-simulation" optimization strategy that combines a brachytherapy treatment planning system (TPS) with biomechanical modeling to improve the feasibility, safety, and effectiveness of radioactive seed implantation for bone metastases (palliative/local control). Conventional TPS is primarily dose-centric and may not adequately account for the mechanical stability of metastatic bone lesions, feasibility of needle trajectories, or risk of seed migration, potentially leading to suboptimal dose distribution or increased post-procedural biomechanics-related adverse events. To address this gap, we integrate a patient-specific finite element biomechanical model into standard TPS to predict load-bearing behavior, fracture risk, needle path stability, and seed migration risk, enabling iterative, dose-mechanics constrained plan optimization. This is a prospective, open-label, randomized controlled trial comparing "TPS + biomechanical dual-simulation" versus conventional TPS. Eligible participants are patients with bone metastases who meet indications for radioactive seed implantation and have pain and/or risk of local progression. In the experimental arm, preoperative imaging segmentation and individualized biomechanical modeling inform coupled optimization of needle trajectories and seed distributions; the control arm receives standard TPS-based planning. All patients undergo image-guided implantation, with post-implant dosimetric verification and standardized follow-up. The primary endpoint is pain response at 3 months (per BPI or VAS, accounting for changes in analgesic use). Secondary endpoints include dosimetric parameters (e.g., D90, V100, conformity index \[CI\], homogeneity index \[HI\]), local control rate and time to progression, seed migration incidence, skeletal-related events (SREs) and pathologic fracture incidence/time, changes in SINS score and functional status (e.g., ECOG, TESS), quality of life (EORTC QLQ-C30), procedure-related complications (CTCAE v5.0), and procedure time/number of needle adjustments. Safety will be assessed at prespecified time points. Imaging will be performed at baseline, post-procedure, and during follow-up, with standardized post-implant dosimetric verification. We hypothesize that the dual-simulation strategy will maintain or improve dose coverage and conformity while reducing seed migration and biomechanics-related complications, thereby improving pain relief and functional outcomes, and providing a more comprehensive, individualized optimization pathway for radioactive seed implantation in bone metastases.

Conditions

• Bone Metastases in Subjects With Advanced Cancer

Interventions

Type	Name	Description
OTHER	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.
OTHER	Conventional TPS Planning	Conventional TPS-driven plan per institutional practice; no biomechanical modeling.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2025-09-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: China