WP 2.8: SENTIVUC- Optic-guided Sentinel Node Mapping in patients with vulva cancer

Introduction: Sentinel node (SN) mapping is a safe staging method in patients with Vulva Cancer (VC) with tumors < 4 cm. In patients with larger tumors, inguinofemoral lymphadenectomy (IL) is the standard procedure. IL causes severe short- and long-term morbidity. The aim of this study is to evaluate the accuracy of SN mapping in patients with primary vulvar cancer and tumors ≥ 4cm, multi-focal or recurrent disease. Methodology: Patients with primary VC, tumor ≥ 4cm, multi-focal, or recurrent disease are included in this prospective observational national study. The study is conducted at the two national departments that undertake the treatment of patients with VC in Denmark (Rigshospitalet and Aarhus University Hospital). The primary outcome is the sensitivity and the negative predictive value of SN mapping. The secondary endpoints are self-reported quality of life and lymphedema. Procedure: All women will undergo SN mapping with ICG followed by IL. All removed SNs will undergo ultra-staging according to a national pathological protocol. Perspectives: An extension of the SN mapping for patients with tumors ≥ 4 cm, multi-focal, or recurrent disease is likely to reduce short- and long-time morbidity. The present study is exploratory due to the rarity of the disease but will provide high-quality population-based data of great international value. Status: A feasibility study of ICG as a combined tracer with Technetium (Tc) has been performed at RH. The study is VEK approved. Both centers (AUH and RH) have acquired an optic camera for the use in the study and pilot testing.

Awarded to: Ligita Paskeviciute Frøding (Rigshospitalet) – CFA2

Awarded grant to support VIP and TAP personnel.