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

NCT07171996 | Recruiting DMC

• 1 other identifier: 960HP20250410
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 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

Keywords

tps; dynamics; osseous metastasis

Outcome Measures

Primary Outcomes (2)

• Pain Response at 3 Months

  Proportion of participants achieving pain response at the treated site 3 months post-implant, defined as ≥2-point absolute reduction or ≥30% relative reduction from baseline in worst pain (BPI-SF item 3 or 0-10 VAS), without an increase in analgesic consumption; if analgesic use changes, response is adjudicated using standardized analgesic-adjusted criteria (e.g., IMMPACT-consistent rules with oral morphine equivalent dose). Pain is collected by trained staff blinded to allocation; centralized, de-identified adjudication applies. Primary analysis compares proportions between arms (risk difference and 95% CI; two-sided α=0.05). Time Frame: Baseline and 3 months post-implant.

  Baseline (≤14 days pre-implant) and 3 months post-implant (±14 days)

• Local Tumor Control (Treated Site)

  Proportion of participants without local progression at the treated lesion, assessed by centralized imaging review. Local progression is defined as any of: (a) ≥20% increase in maximal diameter or volumetric expansion on CT/MRI with an absolute increase of ≥5 mm; (b) new nodular enhancement or soft-tissue extension contiguous with the treated site; (c) unequivocal progression by MD Anderson bone response criteria; or (d) metabolic progression on PET-CT per PERCIST when available. Death without prior local progression is counted as failure in sensitivity analyses; primary analysis censors at last evaluable imaging. Results reported as local control rate and Kaplan-Meier estimates of time to local progression with 95% CIs. Imaging is reviewed by blinded independent radiologists/physicists

  6 months (±30 days), 12 months (±45 days); exploratory at 24 months (±60 days)

Study Arms (2)

Experimental - TPS + Biomechanical Dual-Simulation

EXPERIMENTAL

Single-group assignment using the dual-simulation planning workflow integrating TPS with patient-specific finite element modeling to optimize dose distribution and mechanical safety (fracture risk, needle stability, seed migration). Image-guided implantation is performed per optimized plan; postoperative CT provides dosimetric verification. Outcomes include pain response, dosimetry, biomechanics-related events, and safety.

Other: Dual-Simulation TPS + Biomechanical Planning

Active Comparator - Conventional TPS

ACTIVE COMPARATOR

Preoperative planning using conventional TPS per institutional standards to meet dosimetric goals and OAR constraints; no biomechanical modeling. Image-guided implantation per plan; postoperative CT for seed localization and dosimetric verification. Follow-up schedule identical to the

Other: Conventional TPS Planning

Interventions

Dual-Simulation TPS + Biomechanical Planning OTHER

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.

Experimental - TPS + Biomechanical Dual-Simulation

Conventional TPS Planning OTHER

Conventional TPS-driven plan per institutional practice; no biomechanical modeling.

Active Comparator - Conventional TPS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Li Min: lead

Study Sites (1)

The 960 Hospital of the People's Liberation Army of China

Jinan, Shandong, 250031, China

RECRUITING

Study Officials

• min 李 li

  STUDY DIRECTOR

Central Study Contacts

min li, dr

CONTACT

0531-51665482; 924787237@qq.com

min li

CONTACT

liminyingxiang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking: None (Open Label). Due to the procedural nature of seed implantation, participants and treating clinicians cannot be blinded. To reduce bias, key outcomes are assessed under blinded procedures: (1) centralized, de-identified imaging and dosimetry review by independent radiologists/physicists blinded to allocation; (2) pain and QoL collected via standardized instruments by staff not involved in planning, with pre-specified analgesic adjustment rules; (3) an independent endpoint adjudication committee and the statistical analysis team remain blinded to group assignment, using Arm A/B codes. Allocation is concealed until plan finalization; intraoperative teams are unblinded. Participants are instructed not to disclose perceived assignment to assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Director

Model Details: Two-arm, randomized, open-label trial comparing dual-simulation planning (TPS + patient-specific biomechanical FE model) versus conventional TPS for image-guided radioactive seed implantation in bone metastases.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD and supporting documents will be available starting 12 months after the primary completion date or upon publication of the primary results, whichever occurs first, and will remain available for 5 years thereafter (extensions considered upon justified request).
• Access Criteria: Qualified researchers with a methodologically sound proposal may request access. Required materials include a brief proposal and analysis plan, IRB/ethics approval or exemption (as applicable), and a signed Data Use Agreement. Requests are reviewed by the study's Data Access Committee within \~30 calendar days. Approved users will access a de-identified, analysis-ready dataset via a controlled-access secure environment; raw downloads are restricted. Available materials include: de-identified participant-level dataset, data dictionary/codebook, de-identification schema, redacted protocol, statistical analysis plan, blank CRFs, and analytic code used for primary endpoints (R/Python). Submit requests via the study data portal or email the IPD contact.

Locations

CN (1)