About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known severe history of allergy to Indocyanine Green (ICG) or iodine.
Severe liver dysfunction.
Women who are pregnant or lactating.
Trial design
Single group
Treatments tested in this trial
Indocyanine Green
DrugParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic Accuracy of ICG Fluorescence Imaging (Sensitivity, Specificity, PPV, NPV)
The diagnostic performance of ICG fluorescence imaging in detecting TGCT lesions will be evaluated by comparing the intraoperative fluorescence status (Positive/Negative) with the final histopathological diagnosis (Tumor/Non-tumor) of the resected specimens. The unit of analysis is the individual specimen. The following metrics will be calculated: Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV).
Secondary outcomes
Tumor-to-Background Ratio (TBR)
TBR is a quantitative measure of fluorescence intensity. It will be calculated by dividing the mean fluorescence intensity of the tumor region by the mean fluorescence intensity of the adjacent normal background tissue using image analysis software. Values will be compared between Diffuse-type TGCT (D-TGCT) and Localized-type TGCT (L-TGCT) cohorts.
Incidence of ICG-Related Adverse Events
The number of participants experiencing adverse events related to ICG administration (e.g., allergic reactions, anaphylactic shock) will be monitored and recorded.
Sponsors and contacts
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