Actively Recruiting
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma
Led by Hamilton Health Sciences Corporation · Updated on 2026-04-13
58
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
H
Hamilton Health Sciences Corporation
Lead Sponsor
J
Juravinski Cancer Centre Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult women aged 18 years or older
- Diagnosed with FIGO Stage IB (> 1 mm depth of invasion) or small Stage II (4 cm) vulvar squamous cell carcinoma or cutaneous melanoma
- Candidates for sentinel lymph node technique
- Negative clinical groin examination and/or imaging
- Primary unifocal vulvar tumor size less than 4 cm
You will not qualify if you...
- Prior history of pelvic, vulvovaginal, or inguinal radiation
- Allergy or hypersensitivity to Technetium or Indocyanine Green (ICG)
- Diagnosis of Bartholin gland cancer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V5C2
Actively Recruiting
Research Team
A
Andra Nica, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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