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NCT07171996
Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation
NA trial testing Dual-Simulation TPS + Biomechanical Planning in Bone Metastases in Subjects With Advanced Cancer in 150 participants. Currently enrolling.
1 June 2026
Quick facts
| Lead sponsor | Li Min |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 July 2025 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 June 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Dual-Simulation TPS + Biomechanical Planning
- Conventional TPS Planning
Conditions studied
- Bone Metastases in Subjects With Advanced Cancer — all drugs for Bone Metastases in Subjects With Advanced Cancer →
Sponsor
Li Min
Who can join
Adults 18 to 55, any sex, with Bone Metastases in Subjects With Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07171996
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bone Metastases in Subjects With Advanced Cancer
Currently open trials in the same condition.
- NCT07197645 — Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain · Phase 1 · recruiting
- NCT06987370 — SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue · NA · recruiting
Other Li Min trials
Trials by the same sponsor.
- NCT03849521 — Plaque Calcium Characterization and Ruptured Plaques · unknown
- NCT03850938 — Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07171996 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Li Min
- Last refreshed: 15 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07171996.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing