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Indocyanine Green for Vulvar Cancer Detection

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

Recruiting Observational Study
Vulvar Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
58 (estimated)
Sponsor
Hamilton Health Sciences Corporation · Other
Who this trial is looking for

This trial is looking for women with early stage vulvar cancer to see if a new imaging method is as accurate as the current standard method for finding important lymph nodes. Participants will receive an injection of a dye during their treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am an adult woman aged 18 or older.
  • I have early stage vulvar squamous cell carcinoma or cutaneous melanoma.
  • My vulvar tumor is unifocal and smaller than 4 cm.
  • I do not have any clinical signs of groin cancer.

You may not be able to join if

  • I have had radiation therapy to my pelvic or groin area.
  • I am allergic to Technetium or Indocyanine Green.
  • I have Bartholin gland cancer.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About This Trial

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.

Trial Locations

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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 imagi…
Contacts

Andra Nica, MD

9053879495

nica@hhsc.ca

CONTACT

NCT ID: NCT06039111 Source: ClinicalTrials.gov