Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Musculoskeletal Tumor Center
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
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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