Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma: The IGNITE-V Study
Hamilton Health Sciences Corporation
58 participants
Oct 1, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
SLNs will be detected with ICG alone, labelled as such, and subsequent to that tested with Gamma probe for accuracy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06039111