Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma (IGNITE-V)
Primary Purpose
Vulvar Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ICG alone
Sponsored by
About this trial
This is an interventional diagnostic trial for Vulvar Cancer
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sequential ICG and Technetium Detection
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
the unit of analysis is the number of SLN for each groin.
Full Information
NCT ID
NCT06039111
First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Juravinski Cancer Centre Foundation
1. Study Identification
Unique Protocol Identification Number
NCT06039111
Brief Title
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Juravinski Cancer Centre Foundation
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sequential ICG and Technetium Detection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
ICG alone
Intervention Description
SLNs will be detected with ICG alone, labelled as such, and subsequent to that tested with Gamma probe for accuracy
Primary Outcome Measure Information:
Title
false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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.
Description
the unit of analysis is the number of SLN for each groin.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
2. The proportion of groins for which all SLN extracted were identified by ICG.
Description
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.
Time Frame
2 years
Title
3. The proportion of SLN extracted by ICG for each groin divided by the total number of SLN extracted using ICG and Technetium.
Description
The unit of analysis is the number of SLN for each groin.
Time Frame
2 years
Title
4. Rate of successful mapping of at least 1 SLN (per groin)
Description
proportion
Time Frame
2 years
Title
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.
Description
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.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma
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