Active — Not RecruitingNot Applicable

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

United States22 participantsStarted 2023-11-06

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥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 Exclusion Criteria: * 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

What they're measuring

success of identifying the SLN

Timeframe: 18 months

Trial details

NCT IDNCT06127836

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

View on ClinicalTrials.gov More Vulvar Cancer trials