B7-H3 NIR Imaging for Osteosarcoma Surgery

Last updated: January 11, 2025
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Osteosarcoma

Treatment

a targeted probe B7H3-IRDye800CW

Clinical Study ID

NCT06778603
PKUPH-sarcoma 22
  • Ages 18-60
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients with histologically confirmed osteosarcoma of the limbs.
  1. the patients has not undergone tumor resection.
  1. Age between 18 and 60 years old.
  1. No prior systemic treatment for osteosarcoma.
  1. Measurable disease as assessed by imaging studies (e.g., MRI, CT).
  1. Adequate bone marrow, liver, and renal function.
  1. Written informed consent obtained from the patient.

Exclusion

Exclusion Criteria:

  1. History of other malignancies within the past 5 years.
  1. Pregnancy or lactation.
  1. Known hypersensitivity to any component of the B7H3-based NIR imaging agent.
  1. Uncontrolled intercurrent illness that would preclude safe study participation.
  1. Prior radiation therapy to the target lesion.
  1. Any medical condition that would compromise the patient's ability to undergosurgery or comply with study procedures.
  • 7.Patients not able to sign the Informed Consent.

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: a targeted probe B7H3-IRDye800CW
Phase: 1/2
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Musculoskeletal Tumor Center

    Beijing, Beijing 100044
    China

    Active - Recruiting

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