Using optical guidance for sentinel node biopsy in vulvar cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility of performing sentinel node biopsy in women with vulvar cancer using indocyanine green (ICG) as a single tracer, without lymphoscintigraphy. It focuses on patients with unifocal tumors smaller than 4 cm, specifically those at clinical stages IB and II. Additionally, the study aims to assess the accuracy of combining PET-CT and ultrasound for identifying suspicious lymph nodes and macro-metastases. The approach seeks to improve staging accuracy and potentially reduce the need for more invasive procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with primary vulva cancer, FIGO stage IB (tumor \< 4 cm)
* Patients with unifocal recurrence in the vulva (tumor \< 4 cm) located on the side where the patient is surgically naïve in the groin

Exclusion Criteria:

* Prior irradiation of the vulva or groins
* Prior SNB or inguinal lymphadenectomy in the relevant groin
* Known allergy to ICG or iodine (ICG contains 5% sodium iodine)

Where it's running

• Copenhagen University Hospital
  Copenhagen, Denmark Recruiting

Study contacts

• Study coordinator: Ligita P Frøding
• Email: ligita.paskeviciute.froeding@regionh.dk
• Phone: +4522722972

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using indocyanine green to identify sentinel lymph nodes during breast cancer surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.