Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRigshospitalet, Denmark
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
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
Sentinel Node detection rate
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.
Time frame
Three yearsSecondary outcomes
1
Sensitivity, specificity, PPV and NPV
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
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