RecruitingPhase 1Phase 2NCT06778603

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

Sponsor

Peking University People's Hospital

Enrollment

32 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Osteosarcoma Resection Margins B7-H3 Probe Local Recurrence

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new imaging technique that uses a special dye to make osteosarcoma (bone cancer) visible under a near-infrared (NIR) light camera during surgery. The goal is to help surgeons see the exact edges of the tumor more clearly, which could lead to more precise removal of cancer while sparing healthy tissue. **You may be eligible if...** - You have been diagnosed with osteosarcoma in one of your limbs, confirmed by biopsy - You have not yet had surgery to remove the tumor - You are between 18 and 60 years old - You have not received prior systemic treatment for osteosarcoma - Your tumor is measurable by imaging (MRI or CT) - Your bone marrow, liver, and kidney function are adequate **You may NOT be eligible if...** - You have had another cancer in the past 5 years - You are pregnant or breastfeeding - You are allergic to the imaging agent - You have had radiation therapy to the tumor area - You have serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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