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

Recruiting now · Phase 4

Conditions studied: Giant Cell Tumor of Bone

In brief

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.

Key facts

Study ID

NCT07315828

Run by

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

People needed

40

Starts

2026-01-02

Expected to finish

2026-12-01

Last updated by the study team

2026-01-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known severe history of allergy to Indocyanine Green (ICG) or iodine.
• Severe liver dysfunction.
• Women who are pregnant or lactating.

Where it is running

• Shanghai Sixth People's Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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