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Clinical Trials in Denmark / NCT06029504
Recruiting Observational

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

NCT06029504 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Observational
Started
2023-01-01
Last updated
2023-12-06

Condition(s) studied

Vulvar CancerSentinel Lymph Node

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
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)

Primary outcome measure(s)

  • 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.

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 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 NCT06029504 on ClinicalTrials.gov ↗ ← All trials in Denmark