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

Vulvar Cancer Clinical Trial

— IGNITE-V  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06039111
• Other study ID #: 16315
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: September 2023
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: June 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Juravinski Cancer Centre Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	4. Rate of successful mapping of at least 1 SLN (per groin)	proportion	2 years
Other	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
Primary	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	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