Dermatofibrosarcoma Protuberans (DFSP), Skin Squamous Cell Carcinoma
Conditions
Keywords
near-infrared fluorescence imaging, second window indocyanine green, dermatofibrosarcoma protuberans, skin squamous cell carcinoma
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.
Interventions
The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.
Sponsors
1、 Department of Plastic and Reconstructive Surgery, Peking University Third Hospital
2、 Department of Plastic and Reconstructive Surgery, 1st Medical Center of Chinese PLA General Hospital
3、 Department of Plastic and Reconstructive Surgery, Peking University International Hospital
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with DFSPs or sSCC in heads, extremities or trunk
Exclusion criteria
* seafood/iodine allergy * hyperthyroidism * pregnancy * myasthenia gravis * acute severe hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year local recurrence rate | up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| number of positive margins | through study completion, an average of 2 years |
| sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) | through study completion, an average of 2 years |
| Adverse effects | through study completion, an average of 2 years |
Contacts
Primary ContactDr. Han
Outcome results
None listed