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RECRUITING
NCT07315841
PHASE4

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

Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

View on ClinicalTrials.gov

Summary

This study evaluates the diagnostic accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing Tenosynovial Giant Cell Tumor (TGCT) lesions during surgery. Patients diagnosed with TGCT 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 and potential residual lesions in the surgical bed. 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 resected tissues.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-01-02

Completion Date

2026-12

Last Updated

2026-01-05

Healthy Volunteers

No

Interventions

DRUG

Indocyanine Green

Participants receive an intravenous injection of Indocyanine Green (ICG) at a dose of 0.25-0.5 mg/kg, 1-3 hours prior to surgery. Intraoperatively, a near-infrared fluorescence imaging system is used to guide the exploration. The intervention involves a "verify first, treat later" protocol: it includes diagnostic verification sampling of fluorescence-positive areas and, crucially, therapeutic supplementary resection of residual fluorescent lesions that were missed during standard white-light surgery.

Locations (1)

Shanghai Sixth People's Hospital

Shanghai, China