NCT06778603

B7-H3 NIR Imaging for Osteosarcoma Surgery

Resection of Osteosarcoma in Limbs Navigated by B7H3-based NIR Lmaging: a Prospective, Single-center,Single-arm, Exploratory Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Complete removal of all tumor tissue with a wide surgical margin is essential for the treatment of osteosarcoma (OS). However, it's difficult, sometimes impossible, to achieve due to the invisible small satellite lesions and blurry tumor boundaries. Besides, intraoperative frozen-section analysis of resection margins of OS is often restricted by the hard tissues around OS, which makes it impossible to know whether a negative margin is achieved. Herein, based on the high expression of B7-H3 in OS, a targeted probe B7H3-IRDye800CW is synthesized by conjugating anti-B7H3 antibody and IRDye800CW. This trial is aimed to investigate R0-resection rate and 2-y local recurrence rate after using this probe in Musculoskeletal tumor surgery for osteosarcoma as well as the safety parameters of this probe in human.

Conditions

• Osteosarcoma
• Resection Margins
• B7-H3 Probe
• Local Recurrence

Interventions

Type	Name	Description
DRUG	a targeted probe B7H3-IRDye800CW	B7H3-IRDye800CW was synthesized by conjugating IRDye800CW NHS Ester and Anti-B7H3 antibody.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-06-01
• Completion: 2026-12-31
• First posted: 2025-01-16
• Last updated: 2025-01-16

Locations

1 site across 1 country: China