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

Phase 2Not Yet RecruitingNCT06039111

Hamilton Health Sciences Corporation58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Vulvar Cancer

Interventions

ICG alonePROCEDURE

SLNs will be detected with ICG alone, labelled as such, and subsequent to that tested with Gamma probe for accuracy

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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