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Recruiting NCT06029504

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)

— Observational Vulvar Cancer Sentinel Lymph Node

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Vulvar Cancer, Sentinel Lymph Node. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

Overview

The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor \< 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor \< 4 cm.

Primary outcome measures

  • Sentinel Node detection rate [Time frame: Three years]
Secondary outcome measures (1)
  • Sensitivity, specificity, PPV and NPV [Time frame: Three years]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Copenhagen University Hospital — Copenhagen

Identifiers

NCT: NCT06029504 · H-18020235

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗