NCT06778603RecruitingPhase 1/2
B7-H3 NIR Imaging for Osteosarcoma Surgery
Resection of Osteosarcoma in Limbs Navigated by B7H3-based NIR Lmaging: a Prospective, Single-center,Single-arm, Exploratory Trial
Source: ClinicalTrials.gov · Last updated 16 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 11 Jan 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Sarcoma
- NCT number
- NCT06778603
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 32
- From 1 Jan 2024 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 5\. Prior radiation therapy to the target lesion.
Other illness
- 1\. History of other malignancies within the past 5 years.
- 3\. Known hypersensitivity to any component of the B7H3-based NIR imaging agent.
- 4\. Uncontrolled intercurrent illness that would preclude safe study participation.
- 6\. Any medical condition that would compromise the patient's ability to undergo surgery or comply with study procedures.
Other
- 2\. Pregnancy or lactation.
- 7.Patients not able to sign the Informed Consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Musculoskeletal Tumor Center Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.