Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRigshospitalet, Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with vulva cancer, tumor > 4 cm, multifocal tumor, or local recurrences in vulva
Disqualifiers
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
Trial population
Patients with primary or recurrent vulva cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Sensitivity
Sensitivity of sentinel lymph node mapping
Time frame
Three yearsSecondary outcomes
1
Negative predictive value
Negative predictive value of sentinel lymph node mapping
Time frame
Three yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov