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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Musculoskeletal Tumor Center
RECRUITING
Beijing
Contact Information
Primary
Xiaodong Musculoskeletal Tumor Center of PKUPH, M.D.
tang15877@126.com
+86-88326150
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 32
Treatments
Experimental: experimental group
Related Therapeutic Areas
Sponsors
Collaborators: Simcere Pharmaceutical Group Limited
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov