Clinical trial NCT06610071: NIFR Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose SWIG Technique
Official title: Near-infrared Fluorescence Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose Second Window Indocyanine Green Technique: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Dermatofibrosarcoma Protuberans (DFSP)
Skin Squamous Cell Carcinoma
Keywords: near-infrared fluorescence imaging
second window indocyanine green
dermatofibrosarcoma protuberans
skin squamous cell carcinoma
Lead sponsor: The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Sponsor class: OTHER
Collaborators: name: 1、 Department of Plastic and Reconstructive Surgery, Peking University Third Hospital
name: 2、 Department of Plastic and Reconstructive Surgery, 1st Medical Center of Chinese PLA General Hospital
name: 3、 Department of Plastic and Reconstructive Surgery, Peking University International Hospital
First posted: 2024-09-24
Enrollment: 592
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 2-year local recurrence rate
timeFrame: up to 24 months
Secondary outcomes:
measure: number of positive margins
timeFrame: through study completion, an average of 2 years
measure: sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)
timeFrame: through study completion, an average of 2 years
measure: Adverse effects
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
Study officials:
References: