Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

Rigshospitalet, Denmark100 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Vulva Cancer Sentinel Lymph Node

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Copenhagen University Hospital

Copenhagen, Denmark

RECRUITING

Outcomes

Primary Outcomes

Sensitivity

Sensitivity of sentinel lymph node mapping

Time frame: Three years

Secondary Outcomes

Negative predictive value

Negative predictive value of sentinel lymph node mapping

Time frame: Three years

Central Contacts

Ligita P Frøding

CONTACT

+4522722972 ligita.paskeviciute.froeding@regionh.dk

Data from ClinicalTrials.gov

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