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Clinical Trials in Denmark / NCT06161428
Recruiting Observational

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

NCT06161428 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Observational
Started
2023-05-01
Last updated
2023-12-13

Condition(s) studied

Vulva CancerSentinel Lymph Node

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Sensitivity — Three years
    Sensitivity of sentinel lymph node mapping

Trial sites (1)

FacilityCityRegionStatus
Copenhagen University Hospital Copenhagen Denmark Recruiting

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Other trials for the same condition

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I) Recruiting
Danish Vulva Cancer Recurrence Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06161428 on ClinicalTrials.gov ↗ ← All trials in Denmark