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

Phase 2

Not yet recruiting

• Conditions: Vulvar Cancer
• Interventions: Procedure: ICG alone

• Registration Number: NCT06039111
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Last Update Submitted: 2023-09-08
• Study First Posted: 2023-09-15
• Last Update Posted: 2023-09-15
• Study Start: 2023-10-01
• Primary Completion: 2025-09-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequential ICG and Technetium Detection	ICG alone	-

Primary Outcome Measures

Name	Time	Method
false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin	2 years	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.

Secondary Outcome Measures

Name	Time	Method
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.	2 years	the unit of analysis is the number of SLN for each groin.