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

Running, not enrolling · Not applicable

Conditions studied: Vulvar Cancer

In brief

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.

Key facts

Study ID

NCT06127836

Run by

Memorial Sloan Kettering Cancer Center

People needed

22

Starts

2023-11-06

Expected to finish

2026-11-01

Last updated by the study team

2025-11-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years of age
• Newly diagnosed with vulvar cancer and scheduled to undergo SLN biopsy (patients with squamous cell carcinomas and melanomas will be included)
• Primary tumor ≤4 cm in size
• For patients with squamous cell carcinoma, >1 mm of invasion is required

You may not qualify if…

• Clinically or radiographically enlarged inguinofemoral lymph nodes (if imaging is performed)
• Presence of distant metastases
• Absolute contraindication to radiocolloid Tc-99 or ICG
• Nonsquamous or nonmelanoma histologic subtype

Where it is running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States
• Houston Methodist Cancer Center (Data Collection Only) — Houston, Texas, United States

Full record on ClinicalTrials.gov

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