Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

Recruiting

• Conditions: Vulva Cancer; Sentinel Lymph Node

• Registration Number: NCT06161428
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Status Verified: 2023-12
• Study First Posted: 2023-12-07
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-13
• Primary Completion: 2026-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity	Three years	Sensitivity of sentinel lymph node mapping

Secondary Outcome Measures

Name	Time	Method
Negative predictive value	Three years	Negative predictive value of sentinel lymph node mapping

Trial Locations

Locations (1)

Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark