NCT06610071

NIFR Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose SWIG Technique

Near-infrared Fluorescence Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose Second Window Indocyanine Green Technique: a Multicenter Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 592 (estimated)
• Sponsor: The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dermatofibrosarcoma Protuberans (DFSP)
• Skin Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	ICG administration	The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.
DRUG	ICG administration	The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.
DRUG	ICG administration	The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group
DRUG	ICG administration	The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.

Timeline

• Start date: 2024-10-30
• Primary completion: 2028-12-01
• Completion: 2030-12-30
• First posted: 2024-09-24
• Last updated: 2024-09-24