Condition: Bone Metastases in Subjects With Advanced Cancer · Sponsor: Li Min
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.
This description comes directly from the study's public registry record.
min li, dr · 0531-51665482 · 924787237@qq.com
min li · liminyingxiang@163.com
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| The 960 Hospital of the People's Liberation Army of China | Jinan, Shandong, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07171996