SLN Mapping and ICG Dye for Vulvar Cancer

Tufts University

Status: Not yet enrolling

Conditions: Vulva Cancer

Treatments: Drug: Indocyanine green

Study type: Observational

Funder types: Other

Identifiers

NCT06035068

STUDY00004163

Details and patient eligibility

About

Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked about using a different method to find these lymph nodes using a special dye called Indocyanine Green (ICG). This method involves shining a special camera on the skin. So far, no studies have directly compared the ICG method to the standard blue dye. The ICG camera could make things easier for patients and doctors, and more patients might choose to have their lymph nodes checked with this new method. The goal of our study is to see if using the ICG dye is just as good as the standard method of blue dye.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Combined ICG dye and blue tracer dye

Description:

This study is being done to see if a different way of finding and removing lymph nodes during surgery, using a special camera and a dye called Indocyanine Green (ICG), works as well as the usual method with blue dye plus a radioactive tracer called radiocolloid. By comparing the two ways directly, we hope to make it simpler for people with vulvar cancer to get their lymph nodes checked during surgery.

Treatment:

Drug: Indocyanine green