B7-H3 NIR Imaging for Osteosarcoma Surgery (ROLN-B7-H3)

January 11, 2025 updated by: Xie Lu, Peking University People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaodong Musculoskeletal Tumor Center of PKUPH, M.D.
  • Phone Number: +86-88326150
  • Email: tang15877@126.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Musculoskeletal Tumor Center
        • Contact:
          • Xiaodong Tang/ Musculoskeletal Tumor Center, M.D.
          • Phone Number: +86-88326150
          • Email: tang15877@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Drug: a targeted probe B7H3-IRDye800CW
B7H3-IRDye800CW was synthesized by conjugating IRDye800CW NHS Ester and Anti-B7H3 antibody.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 21 days
According to CTCAE 5.0
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Simcere Pharmaceutical Group Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 11, 2025

First Submitted That Met QC Criteria

January 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 11, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUPH-sarcoma 22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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