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
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• 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).
Locations
Other Locations
Canada
Hamilton Health Sciences
RECRUITING
Hamilton
Contact Information
Primary
Andra Nica, MD
nica@hhsc.ca
9053879495
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 58
Treatments
Sequential ICG and Technetium Detection
ICG alone for the detection of SLN in early vulvar cancer
Related Therapeutic Areas
Sponsors
Leads: Hamilton Health Sciences Corporation
Collaborators: Juravinski Cancer Centre Foundation