Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma

Recruiting now

Conditions studied: Vulvar Cancer

In brief

The aim of this study is to confirm prospectively if the use of near infrared-indocyanine green (NIR-ICG) alone offers similar accuracy and sensitivity to the gold standard dual technique for sentinel lymph node detection in early stage vulvar cancer.

Key facts

Study ID

NCT06039111

Run by

Hamilton Health Sciences Corporation

People needed

58

Starts

2023-10-01

Expected to finish

2026-11-30

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 is running

• Hamilton Health Sciences — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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