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NCT Number: NCT06029504

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

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.

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Key information

Conditions

Vulvar 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 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)

Treatment and study plan

Primary outcomes

  1. Sentinel Node detection rate

    Time frame: Three years

    SN detection rate with ICG and 99mTc-Nanocoll alone perioperatively, where lymphoscintigraphy is blinded, in patients with vulvar cancer (tumor < 4 cm) without clinical suspicion of metastases to the inguinal lymph nodes.

Secondary outcomes

  1. Sensitivity, specificity, PPV and NPV

    Time frame: Three years

    Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FDG PET-CT and US combined with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in the groins

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

Acronym: SENTIVUC

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 8, 2023
Registry last updated
Dec 6, 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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