SLN Mapping and ICG Dye for Vulvar Cancer

Sentinel Lymph Node Mapping and Detection with Indocyanine Green and Spy-Phi Handheld Camera Technology in Early-Stage Vulvar Cancer (PILOT)

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Vulvar cancer
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Female
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Overview
Principal Investigator: Rafael Gonzalez, MD

Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked about using a different method to find these lymph nodes using a special dye called Indocyanine Green (ICG). This method involves shining a special camera on the skin. So far, no studies have directly compared the ICG method to the standard blue dye. The ICG camera could make things easier for patients and doctors, and more patients might choose to have their lymph nodes checked with this new method. The goal of our study is to see if using the ICG dye is just as good as the standard method of blue dye.

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Rafael Gonzalez, MD

Study details
Inclusion Criteria
  • Patients with early-stage SCC (diameter <4 cm) of the vulva without suspicious lymph nodes at
    palpation or imaging who are planned for surgery at Tufts Medical Center.
  • Patients with squamous cell carcinoma, depth of invasion > 1mm
  • Patients with T1 or T2 tumors (FIGO staging) < 4 cm, not encroaching in urethra or anus with
    clinically negative inguinofemoral lymph nodes
Exclusion Criteria
  • Inoperable tumors and tumors with diameter > 4 cm
  • Patients with inguinofemoral lymph nodes that are palpable on clinical exam suspicious for metastases or with cytologically proven inguinofemoral lymph node metastases
  • Radiologically enlarged (>1.5 cm) inguinofemoral lymph node
Study Requirements

This study can be completed in one day, during your lymphedectomy/biopsy for vulvar cancer. There are 4 injections of ICG dye into the same spot as the original blue dye used by your surgeon. The purpose of this research is to determine whether ICG dye is the same as blue dye.