RecruitingNot Applicable

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

Canada58 participantsStarted 2023-10-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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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.

What they're measuring

false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin

Timeframe: 2 years

Trial details

NCT IDNCT06039111

SponsorHamilton Health Sciences Corporation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-30

Contact for this trial

Andra Nica, MD

9053879495 nica@hhsc.ca

View on ClinicalTrials.gov More Vulvar Cancer trials