Using a targeted probe to improve surgery for osteosarcoma
Resection of Osteosarcoma in Limbs Navigated by B7H3-based NIR Lmaging: a Prospective, Single-center,Single-arm, Exploratory Trial
This study is testing a special probe to see if it can help doctors remove osteosarcoma tumors more completely during surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06778603 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with histologically confirmed osteosarcoma of the limbs who have not yet undergone tumor resection.
Not a fit: Patients with a history of other malignancies, uncontrolled illnesses, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce local recurrence rates in osteosarcoma patients by ensuring more complete tumor removal.
How similar studies have performed: While the use of targeted imaging probes in surgery is an emerging field, similar studies have shown promise in improving surgical outcomes for various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.