Menu
Recruiting NCT06161428

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

— Observational Vulva 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: Vulva 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 →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with vulva cancer tumour size \>4 cm, multifocal tumors and local recurrences.

Primary outcome measures

  • Sensitivity [Time frame: Three years]
Secondary outcome measures (1)
  • Negative predictive value [Time frame: Three years]

Eligibility criteria

Inclusion criteria

  • Patients with vulva cancer, tumor > 4 cm, multifocal tumor, or local recurrences in vulva

Exclusion criteria

  • Previous external irradiation of the vulva or groins
  • Former sentinel node or inguinal lymphadenectomy in the relevant groin
  • Known allergy to ICG or iodine
  • Patient is in active treatment for other cancer and/or disseminated disease

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: NCT06161428 · P-2022-946

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗