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NCT Number: NCT06039111

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

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.

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Key information

Conditions

Vulvar Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8V5C2, Canada

Location status: Recruiting

Location contact

Andra Nica

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICG alone

Procedure

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

Primary outcomes

  1. 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.

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.

    Time frame: 2 years

    the unit of analysis is the number of SLN for each groin.

Other outcomes

  1. 2. The proportion of groins for which all SLN extracted were identified by ICG.

    Time frame: 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.

  2. 3. The proportion of SLN extracted by ICG for each groin divided by the total number of SLN extracted using ICG and Technetium.

    Time frame: 2 years

    The unit of analysis is the number of SLN for each groin.

  3. 4. Rate of successful mapping of at least 1 SLN (per groin)

    Time frame: 2 years

    proportion

  4. 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.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andra Nica, MD

CONTACT

[email protected]

9053879495 ext. 64816

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Juravinski Cancer Centre Foundation

Registry information

Official study 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

Acronym: IGNITE-V

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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