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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 4

Conditions: Tenosynovial Giant Cell Tumor

Treatments: Drug: Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT07315841

2025-147 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Tenosynovial Giant Cell Tumor (TGCT), especially the diffuse type, poses a significant surgical challenge due to its infiltrative growth and high recurrence rate. This prospective, single-center, single-arm study aims to evaluate the accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing TGCT lesions during surgery. Eligible patients will receive an intravenous injection of ICG (0.25-0.5 mg/kg) 1-3 hours before surgery. Following standard tumor resection under white light, the surgical bed will be systematically explored using a near-infrared fluorescence imaging system to visualize potential tumor tissues. The surgeon will obtain validation samples from both fluorescence-positive areas and fluorescence-negative background tissues 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 Tenosynovial Giant Cell Tumor (TGCT), including both Localized-type (L-TGCT) and Diffuse-type (D-TGCT), 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 resection, the surgical bed is systematically explored using a near-infrared fluorescence imaging system. The intervention consists of detecting residual fluorescence signals, obtaining verification samples for pathology, and performing supplementary resection of confirmed suspicious lesions to achieve potentially cleaner surgical margins.

Treatment:

Drug: Indocyanine Green