Using a targeted probe to improve surgery for osteosarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of a targeted probe, B7H3-IRDye800CW, to enhance the surgical removal of osteosarcoma tumors. The probe is designed to bind to B7-H3, a protein highly expressed in osteosarcoma, allowing for better visualization of tumor boundaries during surgery. The study aims to evaluate the rate of complete tumor resection (R0-resection) and the local recurrence rate over two years, as well as the safety of the probe in human subjects. Participants will be monitored for their surgical outcomes and any adverse effects related to the probe.

Why it matters

Who can join: the full rules

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.

Where it's running

• Musculoskeletal Tumor Center
  Beijing, Beijing Municipality, China Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.