Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Giant Cell Tumor of Bone Surge
This study evaluates the diagnostic accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing residual lesions of Giant Cell Tumor of Bone (GCTB) in the tumor cavity during surgery. Patients diagnosed with GCTB will receive an intravenous injection of ICG prior to the operation to label tumor tissues. Dur
| Condition(s) | Giant Cell Tumor of Bone |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | This study evaluates the diagnostic accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing residual lesions of Giant Cell Tumor of Bone (GCTB) in the tumor cavity during surgery. Patients diagnosed with GCTB will receive an intravenous injection of ICG prior to the operation to label tumor tissues. During the procedure, surgeons will use a near-infrared fluorescence imaging system to visualize the tumor cavity and identify potential residual lesions after standard curettage. The study aims to determine the sensitivity, specificity, positive predictive value, and negative predictive value of ICG fluorescence imaging by comparing the intraoperative fluorescence findings with the final pathological results of the validation samples. |
| Who can participate | Inclusion Criteria: * Diagnosed with Giant Cell Tumor of Bone(GCTB), via preoperative biopsy or typical imaging (MRI), and scheduled for surgical resection. * Capable of understanding the study and voluntarily signing the written informed consent form. Exclusion Criteria: * Known severe history of allergy to Indocyanine Green (ICG) or iodine. * Severe liver dysfunction. * Women who are pregnant or lactating. |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Shanghai Jiao Tong University Affiliated Sixth People's Hospital |
| Locations | Shanghai, China |
| Start date | 2026-01-02 |
| NCT ID | NCT07315828 |
| Official listing | https://clinicaltrials.gov/study/NCT07315828 |