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

The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Status and phase: Not yet enrolling; Phase 1

Conditions: Dermatofibrosarcoma Protuberans (DFSP); Skin Squamous Cell Carcinoma

Treatments: Drug: ICG administration

Study type: Interventional

Funder types: Other

Identifiers

NCT06610071

CFH2024-2-4043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 592 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with DFSPs or sSCC in heads, extremities or trunk

Exclusion criteria

• seafood/iodine allergy
• hyperthyroidism
• pregnancy
• myasthenia gravis
• acute severe hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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592 participants in 6 patient groups

Patients with DFSP in the first experimental group

Experimental group

Description:

The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.

Treatment:

Drug: ICG administration

Drug: ICG administration

Drug: ICG administration

Drug: ICG administration

Patients with DFSP in the second experimental group

Experimental group

Description:

The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.

Treatment:

Drug: ICG administration

Drug: ICG administration

Drug: ICG administration

Drug: ICG administration

Patients with DFSP in the control group

No Intervention group

Patients with sSCC in the first experimental group

Experimental group

Description:

The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.

Treatment:

Drug: ICG administration

Drug: ICG administration

Drug: ICG administration

Drug: ICG administration

Patients with sSCC in the second experimental group

Experimental group

Description:

The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.

Treatment:

Drug: ICG administration

Drug: ICG administration

Drug: ICG administration

Drug: ICG administration

Patients with sSCC in the control group

No Intervention group