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NCT06161428 Clinical Trial

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

Sentinel Lymph Node Clinical Trial

— SENTIVUC II  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06161428
Other study ID # P-2022-946
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date July 1, 2027

Study information
Verified date December 2023
Source Rigshospitalet, Denmark
Contact Ligita P Frøding
Phone +4522722972
Email ligita.paskeviciute.froeding@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 1, 2027
Est. primary completion date July 1, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Copenhagen University Hospital Copenhagen

Sponsors (2)
Lead Sponsor Collaborator
Rigshospitalet, Denmark Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity Sensitivity of sentinel lymph node mapping Three years
Secondary Negative predictive value Negative predictive value of sentinel lymph node mapping Three years
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