Imaging Probe to Guide Bone Cancer Surgery in Limbs
Tests a glowing imaging probe that helps surgeons find osteosarcoma tumor tissue during limb surgery.
Plain-language title generated from the registry record
Registry title: B7-H3 NIR Imaging for Osteosarcoma Surgery
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06778603, who can take part
Where in China
- Musculoskeletal Tumor CenterBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT06778603
- Record updated
- 16 January 2025
- Original description
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.Read full original descriptionShow less
Resection of Osteosarcoma in Limbs Navigated by B7H3-based NIR Lmaging: a Prospective, Single-center,Single-arm, Exploratory Trial
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.
Inclusion: 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: 5. Prior radiation therapy to the target lesion; 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; 2. Pregnancy or lactation; 7.Patients not able to sign the Informed Consent.