Optimizing radioactive seed implantation for spinal and bone metastases with combined treatment planning and biomechanical simulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label trial compares standard brachytherapy treatment planning system (TPS) alone versus TPS coupled with patient-specific finite element biomechanical modeling to plan percutaneous radioactive seed implantation for bone metastases. Eligible patients with painful and/or progressive osseous metastases are randomized to receive either dual-simulation planning or conventional TPS, followed by image-guided implantation and post-implant dosimetric verification. The dual-simulation arm uses individualized biomechanical models to predict fracture risk, needle path stability, and seed migration, enabling iterative optimization of needle trajectories and seed placement alongside dose constraints. Primary outcome is 3-month pain response adjusted for analgesic use, with secondary endpoints including dosimetry metrics, local control, seed migration, skeletal-related events, functional status, quality of life, and procedure-related complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• The 960 Hospital of the People's Liberation Army of China
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: min li, dr
• Email: 924787237@qq.com
• Phone: 0531-51665482

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.