NCT06778603 B7-H3 NIR Imaging for Osteosarcoma Surgery
| NCT ID | NCT06778603 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | Osteosarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2024-01-01 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06778603 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Osteosarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06778603 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06778603 currently recruiting?
Yes, NCT06778603 is actively recruiting participants. Contact the research team at tang15877@126.com for enrollment information.
Where is the NCT06778603 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06778603 clinical trial?
NCT06778603 is sponsored by Peking University People's Hospital. The trial plans to enroll 32 participants.