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

• ICG guided sentinel lymph node biopsy (Procedure): The surgeon will subsequently inject ICG in accordance with the SLN protocol in the operating room and will identify and remove the SLN by use of near-infrared imaging guidance only. Once the surgeon has identified the SLN in this way, he or she will be unblinded to the results of the lymphoscintigraphy and will use the results of preoperative imaging and an intraoperative gamma counter to confirm the SLNs.

Primary outcomes

• success of identifying the SLN [18 months]: by use of near-infrared imaging with ICG injection. Patients will be eligible for assessment if they undergo attempted SLN mapping by lymphoscintigraphy and near-infrared imaging with ICG injection. The primary endpoint is the accurate identification of the SLN, defined as the uptake of ICG in the proximalmost draining lymph node in the inguinofemoral chain. Evaluate the ability of near-infrared imaging with ICG injection to detect the inguinofemoral SLN in patients with early-stage vulvar cancer, compared with radiocolloid lymphoscintigraphy, the current standard.

Sex: Female, ages: 18 Years to any

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

• Vance Broach, MD, Principal investigator, Memorial Sloan Kettering Cancer Center