B7-H3 NIR Imaging for Osteosarcoma Surgery

Sponsor
Peking University People's Hospital
Study ID
NCT06778603
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • a targeted probe B7H3-IRDye800CW — DRUG
    B7H3-IRDye800CW was synthesized by conjugating IRDye800CW NHS Ester and Anti-B7H3 antibody.

Study Details

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.

Key Dates

First listed
Jan 16, 2025
Start date
Jan 1, 2024
Status verified
Jan 2025
Primary completion
Jun 1, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: experimental group

Primary Outcome Measure

Safety [ Time Frame: 21 days ]

Central Contacts

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