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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Nov 7, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods for finding sentinel lymph nodes (SLNs) in women with early-stage vulvar cancer. Sentinel lymph nodes are the first nodes where cancer is likely to spread, and knowing their status can help guide treatment. The researchers want to see how well a special imaging technique called indocyanine green near-infrared (ICG-NIR) imaging compares to a more traditional method called lymphoscintigraphy. All women participating in this study will be undergoing surgery at Memorial Sloan Kettering Cancer Center, where both imaging methods will be used during their standard treatment.

To participate in this trial, you need to be at least 18 years old and newly diagnosed with vulvar cancer that is 4 cm or smaller in size. You should also be scheduled for an SLN biopsy. The trial is only open to women with certain types of vulvar cancer, specifically squamous cell carcinoma or melanoma. However, if you have enlarged lymph nodes or distant cancer spread, you won't be eligible. If you join the study, you can expect to have both imaging methods used during your surgery, which will help the doctors learn more about which technique is better for detecting SLNs.

Gender

FEMALE

Eligibility criteria

• 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