Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 60Years
All Genders
NCT06778603

B7-H3 NIR Imaging for Osteosarcoma Surgery

Led by Peking University People's Hospital · Updated on 2025-01-16

32

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

P

Peking University People's Hospital

Lead Sponsor

S

Simcere Pharmaceutical Group Limited

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

B7-H3 NIR Imaging for Osteosarcoma Surgery

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with histologically confirmed osteosarcoma of the limbs
  • Patients who have not undergone tumor resection
  • Age between 18 and 60 years old
  • No prior systemic treatment for osteosarcoma
  • Measurable disease as shown by imaging studies (MRI, CT, etc.)
  • Adequate bone marrow, liver, and kidney function
  • Written informed consent obtained from the patient
Not Eligible

You will not qualify if you...

  • History of other cancers within the past 5 years
  • Pregnancy or breastfeeding
  • Known allergy to any part of the B7H3-based near-infrared imaging agent
  • Uncontrolled illness that would prevent safe participation
  • Prior radiation therapy to the tumor site
  • Medical conditions that prevent surgery or study compliance
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Musculoskeletal Tumor Center

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

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Research Team

X

Xiaodong Musculoskeletal Tumor Center of PKUPH, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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