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

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

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 Overview

• Status: Recruiting
• Conditions: Vulvar Cancer
• Intervention / Treatment: Procedure: ICG alone

• Study Type: Observational
• Enrollment (Estimated): 58
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Andra Nica, MD; Phone Number: 64816 9053879495; Email: nica@hhsc.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V5C2
      • Recruiting
      • Hamilton Health Sciences
      • Contact: Andra Nica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Women >= 18 years of age with invasive vulvar cancer Meet criteria for SLN staging (>1mm depth of invasion or >2 cm size, < 4 cm size, no clinically suspicious nodes on physical exam or imaging, no prior groin surgery)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sequential ICG and Technetium Detection; ICG alone for the detection of SLN in early vulvar cancer	Procedure: ICG alone; SLNs will be detected with ICG alone, labelled as such, and subsequent to that tested with Gamma probe for accuracy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
2. The proportion of groins for which all SLN extracted were identified by ICG.	This is defined as the number of groins for whom, all SLN extracted were identified by ICG compared to the number of SLN extracted by ICG and Technetium.	2 years
3. The proportion of SLN extracted by ICG for each groin divided by the total number of SLN extracted using ICG and Technetium.	The unit of analysis is the number of SLN for each groin.	2 years
4. Rate of successful mapping of at least 1 SLN (per groin)	proportion	2 years
5. The specificity of positive SLN detected and number of SLN extracted by ICG will also be calculated, looking at the number of SLN which were detected by ICG alone.	Appropriate caution will be performed when looking at this outcome, understanding that evaluation of whether Technetium detected a SLN will be performed after the SLN is extracted, which is not consistent with normal practice and could be subject to bias.	2 years

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Juravinski Cancer Centre Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Genital Neoplasms, Female; Vulvar Diseases; Vulvar Neoplasms
• Other Study ID Numbers: 16315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes