NCT07315828

Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Giant Cell Tumor of Bone Surgery

A Prospective Study on the Accuracy of Indocyanine Green Fluorescence Imaging for the Visualization of Residual Lesions in the Tumor Cavity During Surgery for Giant Cell Tumor of Bone

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Giant Cell Tumor of Bone (GCTB) poses a significant surgical challenge due to the difficulty in detecting microscopic residual tumor tissues in the bone cavity, which contributes to a high local recurrence rate. This prospective, single-center, single-arm study aims to evaluate the accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing GCTB lesions during surgery. Eligible patients will receive an intravenous injection of ICG (0.25-0.5 mg/kg) 1-6 hours before surgery. Following standard tumor curettage under white light, the bone cavity will be systematically explored using a near-infrared fluorescence imaging system to visualize potential residual tumor tissues. The surgeon will obtain validation samples from fluorescence-positive areas, fluorescence-negative background tissues, and post-treatment beds for blinded pathological assessment. The study will quantify the diagnostic performance of ICG imaging by calculating sensitivity, specificity, positive predictive value, and negative predictive value based on the pathological gold standard, alongside secondary analyses of tumor-to-background ratios and microscopic tumor boundary concordance.

Conditions

• Giant Cell Tumor of Bone

Interventions

Type	Name	Description
DRUG	Indocyanine Green	Participants receive an intravenous injection of Indocyanine Green (ICG) at a dose of 0.25-0.5 mg/kg, 1-6 hours prior to surgery. Intraoperatively, a near-infrared fluorescence imaging system is used to guide the exploration of the bone cavity. The intervention involves a "verify first, treat later" protocol: it includes diagnostic verification sampling of fluorescence-positive areas and, crucially, therapeutic supplementary curettage of residual fluorescent lesions that were missed during standard white-light surgery.

Timeline

• Start date: 2026-01-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-01-02
• Last updated: 2026-01-05

Locations

1 site across 1 country: China