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

NCT06039111 | Recruiting DMC FDA Drug

• 1 other identifier: 16315
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvar Cancer

Outcome Measures

Primary Outcomes (1)

• 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 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.

  2 years

Other Outcomes (4)

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

  2 years

• 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

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

  2 years

Study Arms (1)

Sequential ICG and Technetium Detection

ICG alone for the detection of SLN in early vulvar cancer

Procedure: ICG alone

Interventions

ICG alone PROCEDURE

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

Sequential ICG and Technetium Detection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Juravinski Cancer Centre Foundation: collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8V5C2, Canada

RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Andra Nica, MD

CONTACT

9053879495; nica@hhsc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologic Oncologist

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-09

Locations

CA (1)