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NCT06035068 | NOT YET RECRUITING | Vulva Cancer

SLN Mapping and ICG Dye for Vulvar Cancer
Sponsor:

Tufts Medical Center

Brief Summary:

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.

Condition or disease

Vulva Cancer

Intervention/treatment

Indocyanine green

Study Type : OBSERVATIONAL
Estimated Enrollment : 10 participants
Official Title : Sentinel Lymph Node Mapping and Detection With Indocyanine Green and Spy-Phi Handheld Camera Technology in Early-Stage Vulvar Cancer (PILOT)
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
SLN Mapping and ICG Dye for Vulvar Cancer

Location Details

NCT06035068

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How to Participate

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Locations

Not yet recruiting

United States, Massachusetts

Tufts Medical Center

Boston, Massachusetts, United States, 02111