Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer

VISION (Vulvar ICG SLN Detection) Study: Near-Infrared Imaging With Indocyanine Green Injection for the Detection of Sentinel Lymph Nodes in Vulvar Cancer

The purpose of this study is to compare two types of imaging for sentinel lymph node (SLN) mapping in people with early-stage vulvar cancer. The researchers will compare indocyanine green near-infrared (ICG-NIR) imaging with lymphoscintigraphy. All participants in this study will be scheduled for standard surgical treatment at Memorial Sloan Kettering Cancer Center (MSK). This surgical treatment includes SLN mapping (with both lymphoscintigraphy and ICG-NIR imaging) and SLN biopsy.

Inclusion Criteria:

• ≥18 years of age
• Newly diagnosed with vulvar cancer and scheduled to undergo SLN biopsy (patients with squamous cell carcinomas and melanomas will be included)
• Primary tumor ≤4 cm in size
• For patients with squamous cell carcinoma, >1 mm of invasion is required

Exclusion Criteria:

• Clinically or radiographically enlarged inguinofemoral lymph nodes (if imaging is performed)
• Presence of distant metastases
• Absolute contraindication to radiocolloid Tc-99 or ICG
• Nonsquamous or nonmelanoma histologic subtype