Using indocyanine green (ICG) dye alone to find sentinel lymph nodes in early vulvar cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational comparison uses near-infrared ICG mapping to identify sentinel lymph nodes in adults with early-stage vulvar squamous cell carcinoma and compares detection results to the dual-technique benchmark involving ICG plus technetium. Eligible patients have unifocal tumors less than 4 cm with negative clinical groin exams and are candidates for sentinel lymph node biopsy. Mapped nodes and detection rates will be recorded to calculate sensitivity and accuracy relative to the dual tracer approach. The work is conducted at Hamilton Health Sciences with data collection tied to routine surgical management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adult women (18 years of age) with FIGO Stage IB (\> 1 mm depth of invasion) and small Stage II (4 cm) vulvar squamous cell carcinoma or cutaneous melanoma who are candidates for the Sentinel lymph node technique will be included (Negative clinical groin examination and/or imaging and primary unifocal vulvar tumor size of \< 4 cm).

Exclusion Criteria:

Women with a prior history of pelvic, vulvovaginal or inguinal radiation, with allergy or hypersensitivity to Technetium or ICG, or Bartholin gland cancer will be excluded.

Where it's running

• Hamilton Health Sciences
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Andra Nica, MD
• Email: nica@hhsc.ca
• Phone: 9053879495

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.