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NCT Number: NCT06161428

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

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.

Recruiting

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Key information

Conditions

Vulva Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Sentinel Lymph Node Urogenital Diseases Urogenital Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Ligita P Frøding

CONTACT

[email protected]

+4522722972

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensitivity

    Time frame: Three years

    Sensitivity of sentinel lymph node mapping

Secondary outcomes

  1. Negative predictive value

    Time frame: Three years

    Negative predictive value of sentinel lymph node mapping

Study contacts

Contact information is provided by the study sponsor or research team.

Ligita P Frøding

CONTACT

[email protected]

+4522722972

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Acronym: SENTIVUC II

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 7, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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