Status:
RECRUITING
Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation
Lead Sponsor:
Li Min
Conditions:
Bone Metastases in Subjects With Advanced Cancer
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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 i...
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 ...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Radiologically or histologically confirmed bone metastasis with a lesion suitable for percutaneous radioactive seed implantation (e.g., I-125), per multidisciplinary assessment.
- Indication for local palliation/control: moderate-to-severe pain at lesion (e.g., BPI/VAS ≥4) and/or imaging evidence of progression or high-risk features warranting local therapy.
- Measurable/evaluable target lesion on CT/MRI; target location accessible for needle placement per institutional practice.
- ECOG performance status 0-2.
- Estimated life expectancy ≥3 months.
- Adequate hemostasis: platelets ≥80×10\^9/L, INR ≤1.5 (or per protocol), and able to hold/bridge anticoagulation as clinically indicated.
- Adequate organ function to undergo the procedure and anesthesia/sedation per site standards.
- Able to undergo required imaging (CT; MRI if applicable).
- Willing and able to provide written informed consent and comply with follow-up.
- For women of childbearing potential and men with partners of childbearing potential: agreement to use effective contraception during and for the protocol-defined period after implantation.
Exclusion
- Need for urgent surgical decompression or stabilization (e.g., acute/impending neurologic compromise, unstable pathologic fracture) that precludes percutaneous implantation at this time.
- Uncorrected coagulopathy or ongoing antithrombotic therapy that cannot be safely managed periprocedurally.
- Active systemic or local infection at/near the planned access route.
- Diffuse marrow replacement or extensive cortical destruction where percutaneous implantation is unsafe or unlikely to achieve local control without stabilization, per MDT judgment.
- Prior radiation or surgery to the index lesion that, in the investigator's opinion, makes additional seed implantation unsafe or non-beneficial; postoperative bed without a discrete target for seed placement.
- Known hypersensitivity to materials/agents required for the procedure (e.g., contrast) not amenable to premedication or alternative imaging.
- Uncontrolled medical conditions posing prohibitive procedural risk (e.g., severe cardiopulmonary disease, uncontrolled hypertension/arrhythmia).
- Pregnant or breastfeeding.
- Inability to lie still or contraindications to required imaging/sedation not correctable.
- Concurrent participation in another interventional study that could confound efficacy/safety assessment at the treated site.
- Any condition that, in the investigator's judgment, would interfere with protocol adherence, safety monitoring, or outcome assessment.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07171996
Start Date
July 1 2025
End Date
June 1 2027
Last Update
September 15 2025
Active Locations (1)
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1
The 960 Hospital of the People's Liberation Army of China
Jinan, Shandong, China, 250031