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

NCT06127836 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-11-05

No results posted yet for this study

Summary

The purpose of this study is to compare two types of imaging for sentinel lymph node (SLN) mapping in people with early-stage vulvar cancer. The researchers will compare indocyanine green near-infrared (ICG-NIR) imaging with lymphoscintigraphy. All participants in this study will be scheduled for standard surgical treatment at Memorial Sloan Kettering Cancer Center (MSK). This surgical treatment includes SLN mapping (with both lymphoscintigraphy and ICG-NIR imaging) and SLN biopsy.

Conditions

  • Vulvar Cancer

Interventions

PROCEDURE

ICG guided sentinel lymph node biopsy

The surgeon will subsequently inject ICG in accordance with the SLN protocol in the operating room and will identify and remove the SLN by use of near-infrared imaging guidance only. Once the surgeon has identified the SLN in this way, he or she will be unblinded to the results of the lymphoscintigraphy and will use the results of preoperative imaging and an intraoperative gamma counter to confirm the SLNs.

Sponsors & Collaborators

Principal Investigators

  • Vance Broach, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127836 on ClinicalTrials.gov