Actively Recruiting
Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation
Led by Li Min · Updated on 2025-09-15
150
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Radiologically or histologically confirmed bone metastasis suitable for percutaneous radioactive seed implantation
- Moderate to severe pain at the lesion or imaging evidence of progression or high-risk features indicating local therapy
- Measurable or evaluable target lesion on CT or MRI accessible for needle placement
- ECOG performance status between 0 and 2
- Estimated life expectancy of at least 3 months
- Adequate blood clotting function and ability to manage anticoagulation as needed
- Adequate organ function to safely undergo procedure and anesthesia or sedation
- Ability to undergo required imaging (CT; MRI if applicable)
- Willingness and ability to provide informed consent and comply with follow-up
- Agreement to use effective contraception during and after treatment for women of childbearing potential and men with partners of childbearing potential
You will not qualify if you...
- Need for urgent surgical decompression or stabilization that prevents percutaneous implantation
- Uncorrected bleeding problems or anticoagulation that cannot be safely managed
- Active systemic or local infection near the planned treatment area
- Extensive bone marrow replacement or bone destruction making implantation unsafe or ineffective
- Previous radiation or surgery to the target lesion making additional implantation unsafe or non-beneficial
- Known allergies to materials used in the procedure that cannot be managed
- Uncontrolled serious medical conditions posing high procedural risk
- Pregnancy or breastfeeding
- Inability to lie still or contraindications to required imaging or sedation that cannot be corrected
- Participation in another interventional study that may interfere with this study
- Any condition that could interfere with following the study protocol, safety monitoring, or outcome assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The 960 Hospital of the People's Liberation Army of China
Jinan, Shandong, China, 250031
Actively Recruiting
Research Team
M
min li, dr
CONTACT
M
min li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here