This research study will evaluate how near-infrared fluorescence (NIRF) imaging with low-dose second window indocyanine green (ICG) can assist in the radical resection and pathologic diagnosis of malignant soft tissue sarcoma, such as dermatofibrosarcoma protuberans (DFSP) and skin squamous cell carcinoma (sSCC) during surgery.
To improve the accuracy of radical resection by reducing the risk of missed diagnosis of positive margin, this study will explore clinical application of near-infrared fluorescence imaging with modified low-dose SWIG technique in guiding radical resection of malignant soft tissue tumor. The investigators conduct a multi-center, multi-subgroup, prospective randomized controlled trial. The participants will be first stratified according to histological type involving dermatofibrosarcoma protuberans (DFSP) and skin squamous cell carcinoma (sSCC). The patients with DFSP or sSCC will be then randomly assigned to three groups. Patients in the control group will not receive ICG administration. The ICG was injected intravenously 24 hours before surgery, at a dose of 0.25 mg/kg in the first experimental group and 25 mg/patient in the second experimental group, respectively. The patients in the control groups will undergo traditional assessment of surgical margins.The patients in the experimental groups, on the other hand, will be scheduled to intraoperative near-infrared fluorescence imaging to scan gross tumor, tumor bed and cross-sectional specimen. The 2-year local recurrence rate will be regarded as primary outcome. The number of positive margins will be compared among groups. The investigators will also calculate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) with 95% confidence intervals based on fluorescent signal of tumor bed in the experimental groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.
The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.
The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group
2-year local recurrence rate
Time frame: up to 24 months
number of positive margins
Time frame: through study completion, an average of 2 years
sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)
Time frame: through study completion, an average of 2 years
Adverse effects
Time frame: through study completion, an average of 2 years
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The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.