IGNITE-V: Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequential ICG and Technetium Detection
|
Procedure: ICG alone
SLNs will be detected with ICG alone, labelled as such, and subsequent to that tested with Gamma probe for accuracy
|
Outcome Measures
Primary Outcome Measures
- false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin [2 years]
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.
Secondary Outcome Measures
- 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. [2 years]
the unit of analysis is the number of SLN for each groin.
Other Outcome Measures
- 2. The proportion of groins for which all SLN extracted were identified by ICG. [2 years]
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.
- 3. The proportion of SLN extracted by ICG for each groin divided by the total number of SLN extracted using ICG and Technetium. [2 years]
The unit of analysis is the number of SLN for each groin.
- 4. Rate of successful mapping of at least 1 SLN (per groin) [2 years]
proportion
- 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. [2 years]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hamilton Health Sciences Corporation
- Juravinski Cancer Centre Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16315