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SENTIVUC I: Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT06029504
Collaborator
Aarhus University Hospital (Other)
115
Enrollment
1
Location
60
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    115 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
    Actual Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Sentinel Node detection rate [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 Outcome Measures

    1. Sensitivity, specificity, PPV and NPV [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Copenhagen University Hospital Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark
    • Aarhus University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ligita Paskeviciute Froding, MD, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT06029504
    Other Study ID Numbers:
    • H-18020235
    First Posted:
    Sep 8, 2023
    Last Update Posted:
    Sep 8, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vulvar Neoplasms

    Study Results

    No Results Posted as of Sep 8, 2023