Recruiting

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

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT06039111

Conditions

Vulvar Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

ICG alone

Study Details

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.

Conditions

Vulvar Cancer

Study ID

NCT06039111

Start date

Oct 1, 2023

Status verified date

Sep, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

58 participants

Anticipated

Interventions and Outcome Measures

Arms

Sequential ICG and Technetium Detection

ICG alone for the detection of SLN in early vulvar cancer

Interventions

ICG alone

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

Primary outcome measure

false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Andra Nica, MD

9053879495 nica@hhsc.ca

Locations

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V5C2

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Apr 13, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2026-04-13.