Bone Metastases in Subjects With Advanced CancerNCT07171996
Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation
A study testing Dual-Simulation TPS + Biomechanical Planning and Conventional TPS Planning in people with Bone Metastases in Subjects With Advanced Cancer, run by Li Min at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bone Metastases in Subjects With Advanced Cancer
- What is being tested?
- Dual-Simulation TPS + Biomechanical Planning and Conventional TPS Planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
min li contact
China1 site, 1 recruiting
- Recruiting
The 960 Hospital of the People's Liberation Army of China
Jinan, Shandong, 250031
min li, dr, 0531-51665482, 924787237@qq.com
About this study
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.
Read the 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 effectiveness of radioactive seed implantation for bone metastases (palliative/local control). Conventional TPS is primarily dose-centric and may not adequately account for the mechanical stability of metastatic bone lesions, feasibility of needle trajectories, or risk of seed migration, potentially leading to suboptimal dose distribution or increased post-procedural biomechanics-related adverse events. To address this gap, we integrate a patient-specific finite element biomechanical model into standard TPS to predict load-bearing behavior, fracture risk, needle path stability, and seed migration risk, enabling iterative, dose-mechanics constrained plan optimization.
This is a prospective, open-label, randomized controlled trial comparing "TPS + biomechanical dual-simulation" versus conventional TPS. Eligible participants are patients with bone metastases who meet indications for radioactive seed implantation and have pain and/or risk of local progression. In the experimental arm, preoperative imaging segmentation and individualized biomechanical modeling inform coupled optimization of needle trajectories and seed distributions; the control arm receives standard TPS-based planning. All patients undergo image-guided implantation, with post-implant dosimetric verification and standardized follow-up.
The primary endpoint is pain response at 3 months (per BPI or VAS, accounting for changes in analgesic use). Secondary endpoints include dosimetric parameters (e.g., D90, V100, conformity index [CI], homogeneity index [HI]), local control rate and time to progression, seed migration incidence, skeletal-related events (SREs) and pathologic fracture incidence/time, changes in SINS score and functional status (e.g., ECOG, TESS), quality of life (EORTC QLQ-C30), procedure-related complications (CTCAE v5.0), and procedure time/number of needle adjustments. Safety will be assessed at prespecified time points. Imaging will be performed at baseline, post-procedure, and during follow-up, with standardized post-implant dosimetric verification.
We hypothesize that the dual-simulation strategy will maintain or improve dose coverage and conformity while reducing seed migration and biomechanics-related complications, thereby improving pain relief and functional outcomes, and providing a more comprehensive, individualized optimization pathway for radioactive seed implantation in bone metastases.
- Being tested
- Dual-Simulation TPS + Biomechanical Planning, Conventional TPS Planning
- Keywords
- tps, dynamics, osseous metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Simulation TPS + Biomechanical PlanningOther
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.
Conventional TPS PlanningOther
Conventional TPS-driven plan per institutional practice; no biomechanical modeling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Conventional TPS Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months (±30 days), 12 months (±45 days); exploratory at 24 months (±60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Jul 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Metastases in Subjects With Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Min
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Min, Jinan Military General Hospital
- Investigators
- min 李 li, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171996
- Sponsor's protocol ID
- 960HP20250410
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data including baseline demographics and clinical characteristics; lesion site and imaging features; planning inputs (e.g., TPS parameters, seed model), dosimetry metrics (D90, V100, CI, HI), biomechanical model outputs (stress/strain maps summarized, fracture/migration risk scores), procedure details (needle count/paths, procedure time, intraoperative deviations), safety data (AEs/SAEs per CTCAE v5.0), analgesic use, pain scores (BPI/VAS), functional status (ECOG/TESS), quality of life (EORTC QLQ-C30), and imaging-derived efficacy endpoints (local control/progression dates and assessments). Dates will be shifted or bucketed to protect privacy; direct identifiers will be removed.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation
- ClinicalTrials.gov ID
- NCT07171996
- Acronym / sponsor ID
- 960HP20250410
- Keywords
- tps, dynamics, osseous metastasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Li MinUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 effectiveness of radioactive seed implantation for bone metastases (palliative/local control). Conventional TPS is primarily dose-centric and may not adequately account for the mechanical stability of metastatic bone lesions, feasibility of needle trajectories, or risk of seed migration, potentially leading to suboptimal dose distribution or increased post-procedural biomechanics-related adverse events. To address this gap, we integrate a patient-specific finite element biomechanical model into standard TPS to predict load-bearing behavior, fracture risk, needle path stability, and seed migration risk, enabling iterative, dose-mechanics constrained plan optimization.
This is a prospective, open-label, randomized controlled trial comparing "TPS + biomechanical dual-simulation" versus conventional TPS. Eligible participants are patients with bone metastases who meet indications for radioactive seed implantation and have pain and/or risk of local progression. In the experimental arm, preoperative imaging segmentation and individualized biomechanical modeling inform coupled optimization of needle trajectories and seed distributions; the control arm receives standard TPS-based planning. All patients undergo image-guided implantation, with post-implant dosimetric verification and standardized follow-up.
The primary endpoint is pain response at 3 months (per BPI or VAS, accounting for changes in analgesic use). Secondary endpoints include dosimetric parameters (e.g., D90, V100, conformity index [CI], homogeneity index [HI]), local control rate and time to progression, seed migration incidence, skeletal-related events (SREs) and pathologic fracture incidence/time, changes in SINS score and functional status (e.g., ECOG, TESS), quality of life (EORTC QLQ-C30), procedure-related complications (CTCAE v5.0), and procedure time/number of needle adjustments. Safety will be assessed at prespecified time points. Imaging will be performed at baseline, post-procedure, and during follow-up, with standardized post-implant dosimetric verification.
We hypothesize that the dual-simulation strategy will maintain or improve dose coverage and conformity while reducing seed migration and biomechanics-related complications, thereby improving pain relief and functional outcomes, and providing a more comprehensive, individualized optimization pathway for radioactive seed implantation in bone metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental - TPS + Biomechanical Dual-Simulation | Experimental | Other: Dual-Simulation TPS + Biomechanical PlanningSingle-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. |
| Active Comparator - Conventional TPS | Active comparator | Other: Conventional TPS PlanningPreoperative 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-Simulation TPS + Biomechanical PlanningCombines 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 | Experimental - TPS + Biomechanical Dual-Simulation |
| Conventional TPS PlanningConventional TPS-driven plan per institutional practice; no biomechanical modeling. | Other | Active Comparator - Conventional TPS |
Primary outcome
Pain Response at 3 Months
Time frame: Baseline (≤14 days pre-implant) and 3 months post-implant (±14 days)
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.
Local Tumor Control (Treated Site)
Time frame: 6 months (±30 days), 12 months (±45 days); exploratory at 24 months (±60 days)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified participant-level data including baseline demographics and clinical characteristics; lesion site and imaging features; planning inputs (e.g., TPS parameters, seed model), dosimetry metrics (D90, V100, CI, HI), biomechanical model outputs (stress/strain maps summarized, fracture/migration risk scores), procedure details (needle count/paths, procedure time, intraoperative deviations), safety data (AEs/SAEs per CTCAE v5.0), analgesic use, pain scores (BPI/VAS), functional status (ECOG/TESS), quality of life (EORTC QLQ-C30), and imaging-derived efficacy endpoints (local control/progression dates and assessments). Dates will be shifted or bucketed to protect privacy; direct identifiers will be removed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
min li contact
min 李 li study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Simulation TPS + Biomechanical Planning and Conventional TPS Planning in people with Bone Metastases in Subjects With Advanced Cancer, run by Li Min at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact min li, dr (0531-51665482, 924787237@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Response at 3 Months (time frame: Baseline (≤14 days pre-implant) and 3 months post-implant (±14 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.