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

NCT07171996 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

  • Bone Metastases in Subjects With Advanced Cancer

Interventions

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.

Sponsors & Collaborators

  • Li Min

    lead OTHER

Principal Investigators

  • min 李 li

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-06-01
Completion
2027-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07171996 on ClinicalTrials.gov