About this trial
ICG fluorescence imaging will be applied during the intralesional curettage of giant cell tumor of bone in the limbs. This study aims to preliminarily explore whether ICG fluorescent-guided curettage could find small residual tumors and reduce the recurrence rate of tumor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
. Aged 18-65.
Biopsy confirmed giant cell tumor of bone.
The lesions located in the limbs.
This operation is the initial treatment.
Disqualifiers
. Known allergy to iodine contrast, indocyanine green or bone cement.
. Severe hepatic and renal insufficiency.
. During pregnancy or lactation.
. Have other malignant tumors and are receiving related medical treatment.
Trial design
Single group
Treatments tested in this trial
ICG (Indocyanine Green)
DrugPatients will be receive intravenously administrated at a dose of 2 mg/kg on the day before surgery. The drug was dissolved into 250 mL of normal saline and administered using a light-proof infusion apparatus. The time course of administration was 60 min. NIR imaging will be performed during surgery to help identify small tumor residuals.
Treatment groups
Trial outcomes
Primary outcomes
local recurrence rate of tumor
To explore whether based on ICG-based-NIR fluorescence imaging assisted intralesional curettage can reduce the local recurrence rate of giant cell tumor of bone in limbs.
Secondary outcomes
Accuracy of ICG prediction tumor residuals
To explore the accuracy of ICG fluorescence in detection of small residual tumor lesions and calculate the sensitivity, specificity, positive predictive value, negative predictive value.
Correlation between fluorescence intensity and pathology findings of tumor residuals
To explore the correlation between ICG fluorescence intensity and accuracy of detection of residual tumor lesions.
Sponsors and contacts
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Tang Xiaodong
Lead sponsor
Peking University People's Hospital
Sponsor institution