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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 4

Conditions: Giant Cell Tumor of Bone

Treatments: Drug: Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT07315828

2025-146

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

ICG Fluorescence Imaging Group

Experimental group

Description:

All enrolled participants receive ICG fluorescence-guided surgery. Following standard tumor curettage, the bone cavity is systematically explored using a near-infrared fluorescence imaging system. The intervention consists of detecting residual fluorescence signals, obtaining verification samples for blinded pathological assessment, and performing supplementary curettage of confirmed suspicious lesions to achieve potentially cleaner surgical margins.

Treatment:

Drug: Indocyanine Green