NCT06778603

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
8mo left

Started Jan 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2024Dec 2026

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 11, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

January 11, 2025

Last Update Submit

January 11, 2025

Conditions

OsteosarcomaResection MarginsB7-H3 ProbeLocal Recurrence

Keywords

osteosarcomaresection marginsB7-H3 Targeted Probelocal recurrence rate

Outcome Measures

Primary Outcomes (1)

  • Safety

    According to CTCAE 5.0

    21 days

Study Arms (1)

experimental group

EXPERIMENTAL
Drug: a targeted probe B7H3-IRDye800CW

Interventions

a targeted probe B7H3-IRDye800CWDRUG

B7H3-IRDye800CW was synthesized by conjugating IRDye800CW NHS Ester and Anti-B7H3 antibody.

experimental group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Musculoskeletal Tumor Center

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (1)

  • Zeng F, Li C, Wang H, Wang Y, Ren T, He F, Jiang J, Xu J, Wang B, Wu Y, Yu Y, Hu Z, Tian J, Wang S, Tang X. Intraoperative Resection Guidance and Rapid Pathological Diagnosis of Osteosarcoma using B7H3 Targeted Probe under NIR-II Fluorescence Imaging. Adv Sci (Weinh). 2024 Sep;11(33):e2310167. doi: 10.1002/advs.202310167. Epub 2024 Mar 19.

    PMID: 38502871BACKGROUND

MeSH Terms

Conditions

OsteosarcomaMargins of Excision

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaMorphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaodong Musculoskeletal Tumor Center of PKUPH, M.D.

CONTACT

+86-88326150tang15877@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Musculoskeletal Tumor Center

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 16, 2025

Study Start

January 1, 2024

Primary Completion

June 1, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)