A Prospective Study Evaluating the Accuracy of Indocyanine Green Fluorescence Imaging in Detecting Lesions During Tenosynovial Giant Cell Tumor Surgery

What this Trial Is About

Researchers are studying the use of Indocyanine Green (ICG) fluorescence imaging to improve the visualization of Tenosynovial Giant Cell Tumor (TGCT) lesions during surgery. TGCT, especially the diffuse type, is challenging to remove completely because of its infiltrative growth and high chance of coming back. This prospective, single-center study aims to assess how accurately ICG imaging detects tumor tissues compared to standard methods by analyzing its sensitivity, specificity, and predictive values against final pathological results. Participants will receive an intravenous injection of ICG at a dose between 0.25 and 0.5 mg/kg, given 1 to 3 hours before surgery. After the usual tumor removal under normal light, surgeons will use a near-infrared fluorescence imaging system to carefully scan the surgical area for any remaining tumor tissues that glow with ICG. The surgeon will collect tissue samples from areas that show fluorescence and from areas that do not, to verify the imaging accuracy. If suspicious fluorescent tissues are found, additional removal will be performed. During the study, researchers will monitor the diagnostic accuracy of ICG imaging by comparing intraoperative fluorescence findings to pathology results available up to one week after surgery. They will also measure tumor-to-background signal ratios during surgery and track any adverse events related to ICG injection up to 24 hours after surgery. This comprehensive approach aims to improve surgical outcomes for patients with TGCT by potentially enhancing tumor detection and removal.

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