Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma

Launched by HAMILTON HEALTH SCIENCES CORPORATION · Sep 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a method to help doctors find sentinel lymph nodes in women with early-stage vulvar cancer. Sentinel lymph nodes are the first nodes that cancer cells are likely to spread to, so finding them is important for determining the best treatment. The researchers want to see if using a special dye called indocyanine green (ICG) alone is just as effective as a combination of ICG and another dye called Technetium for detecting these lymph nodes.

To participate in this trial, women must be at least 18 years old and have certain types of vulvar squamous cell carcinoma or melanoma that meet specific criteria, such as having a certain depth of invasion and a tumor size of 4 cm or less. Women who have had previous radiation treatments in the pelvic area, have allergies to the dyes used, or have certain types of cancer are not eligible. Participants will receive the ICG dye, and the study will closely monitor how well it works compared to the traditional method. This research aims to improve the accuracy of lymph node detection, which can lead to better treatment outcomes for women facing this type of cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Adult women (18 years of age) with FIGO Stage IB (\> 1 mm depth of invasion) and small Stage II (4 cm) vulvar squamous cell carcinoma or cutaneous melanoma who are candidates for the Sentinel lymph node technique will be included (Negative clinical groin examination and/or imaging and primary unifocal vulvar tumor size of \< 4 cm).
• Exclusion Criteria:
• • Women with a prior history of pelvic, vulvovaginal or inguinal radiation, with allergy or hypersensitivity to Technetium or ICG, or Bartholin gland cancer will be excluded.