A research project by Ligita Paskeviciute Frøding
Background: Sentinel node (SN) procedure is a safe staging method in patients with vulva cancer (VC). Near-infrared fluorescence imaging using indocyanine green (ICG) has recently been introduced to improve the visual intraoperative SN identification.
Aim: The overall aim of this study is to optimize the SN procedure in patients with VC. Furthermore, to investigate whether SN procedure can be performed without the use of lymphscintigraphy using ICG as a mono-tracer in women with VC, unifocal tumors < 4 cm and to uncover whether we can optimize logistics and economics associated with preoperative scintigraphy as well as reduce patient-related discomfort with preoperative tracer injection. Furthermore, to investigate new indications for SN procedure in patients with VC, tumors > 4 cm, multifocal tumors and local recurrences.
Methods: This is a prospective exploratory multi-center study performed in two departments treating patients with VC in Denmark (Århus University Hospital and Rigshospitalet). The study consists of two study groups according to the size of the primary tumor in vulva (tumor < 4 and ≥ 4 cm). The primary outcome in study I is SN detection rate with ICG alone perioperatively, where scintigraphy is blinded and in study II- sensitivity and NPV of SN procedure for the identification of lymphnode metastases in groins. It is planned to include 100 patients in each study group during the next 3 years. Study has received funding from KB and Alfred Benzon foundation.