SLN Mapping and ICG Dye for Vulvar Cancer

Launched by TUFTS MEDICAL CENTER · Sep 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new method for locating lymph nodes in women with early-stage vulvar cancer. Traditionally, doctors use a blue dye to help find these lymph nodes for biopsy, but this process can be complicated and requires a lot of coordination. The study is exploring whether a different dye called Indocyanine Green (ICG), which can be seen with a special camera, works just as well as the blue dye. The aim is to see if using ICG can make the procedure easier for both patients and doctors.

To be eligible for this trial, participants need to be women aged 18 or older with early-stage squamous cell carcinoma (a type of skin cancer) of the vulva that is less than 4 cm in size and has no suspicious lymph nodes. Those with larger tumors or other complications, like signs of cancer spread, cannot participate. If you join the study, you can expect to have your lymph nodes checked using the ICG method, and researchers will compare the results to the traditional blue dye method. This trial is still in the planning stages and is not yet recruiting participants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older
• • 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
• • Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible
• • Preoperative imaging do not show enlarged (\<1.5 cm)/ suspicious nodes
• • Willing and able to give informed consent
• 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 nodes
• • Patients with multifocal tumors
• • Pregnancy