Vulvar CancerIGNITE-VNCT06039111
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma
An observational study of Vulvar Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Cancer
- What is being tested?
- ICG alone
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2023to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8V5C2
Andra Nica
About this study
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
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
- Being tested
- ICG alone
- Medical subject headings
- Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG aloneProcedure or surgery
SLNs will be detected with ICG alone, labelled as such, and subsequent to that tested with Gamma probe for accuracy
| Study group | Role | What they receive |
|---|---|---|
| Sequential ICG and Technetium Detection | ICG alone for the detection of SLN in early vulvar cancer Receives: Procedure: ICG alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Oct 2023
- Primary completion30 May 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Juravinski Cancer Centre Foundation
- Responsible party
- Principal investigator, Andra Nica, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039111
- Sponsor's protocol ID
- 16315
- Acronym
- IGNITE-V
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06039111
- Acronym / sponsor ID
- IGNITE-V / 16315
- Conditions
- Vulvar Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Juravinski Cancer Centre Foundation
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential ICG and Technetium Detection | – | Procedure: ICG aloneICG alone for the detection of SLN in early vulvar cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG aloneSLNs will be detected with ICG alone, labelled as such, and subsequent to that tested with Gamma probe for accuracy | Procedure or surgery | Sequential ICG and Technetium Detection |
Primary outcome
false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin
Time frame: 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.
1 secondary outcome
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.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvar Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andra Nica, MD (9053879495 ext. 64816, nica@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.