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.
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Women \>= 18 years of age with invasive vulvar cancer Meet criteria for SLN staging (\>1mm depth of invasion or \>2 cm size, \< 4 cm size, no clinically suspicious nodes on physical exam or imaging, no prior groin surgery)
Cohort
Prospective
ICG alone
Procedure/SurgerySLNs will be detected with ICG alone, labelled as such, and subsequent to that tested with Gamma probe for accuracy
false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin
This will be calculated as the number of groins for which positive SLN were missed using ICG alone; i.e. the number of groins for which ICG did not detect a positive SLN but was detected by ICG and Technetium, divided by the number of groins for which surgery was performed.
1. The proportion of positive SLN detected by ICG for each groin divided by the total number of positive SLN detected using ICG and Technetium.
the unit of analysis is the number of SLN for each groin.
2. The proportion of groins for which all SLN extracted were identified by ICG.
This is defined as the number of groins for whom, all SLN extracted were identified by ICG compared to the number of SLN extracted by ICG and Technetium.
3. The proportion of SLN extracted by ICG for each groin divided by the total number of SLN extracted using ICG and Technetium.
The unit of analysis is the number of SLN for each groin.
4. Rate of successful mapping of at least 1 SLN (per groin)
proportion
5. The specificity of positive SLN detected and number of SLN extracted by ICG will also be calculated, looking at the number of SLN which were detected by ICG alone.
Appropriate caution will be performed when looking at this outcome, understanding that evaluation of whether Technetium detected a SLN will be performed after the SLN is extracted, which is not consistent with normal practice and could be subject to bias.
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Hamilton Health Sciences Corporation
Lead sponsor
Juravinski Cancer Centre Foundation
Collaborator
