Introduction/Background Nowadays sentinel lymph nodes (SLN) biopsy is a well accepted technique in vulvar cancer patients with negative groins. The standard for SLN detection uses peritumoral radioisotope injection to locate the groin nodes. A novel non-radioactive method for identifyning SLN uses a superparamagnetic iron oxide tracer (Sienna+®) injected peritumorally and a magnenometer probe (Sentimag®) to find the nodes.
We created the SARVU study (Sentinel Lymph Nodes Detection with Sentimag against Radiotracer in Vulvar Cancer) to compare and validate the use of ferromagnetic technique of SLN detection with iron oxide tracer (Sienna+®) and magnenometer probe (Sentimag®) vs. standard procedure.
Methodology We included 20 patients with squamous vulvar tumour less then 4 cm and negative lymph nodes in imaging pre-op work-up. The primary endpoint was the propotion of succesful SLN detection with Siena+® vs. Tc99. The secondary endopoints were: the average of SLN per patient, the proportion of SLN detected (nodal detection rate), the propotion of pathologically positive results (malignancy rate) per patient and per node.
Results SLN procedure in both studied methods showed equal average distribution (3.3 SLN per patient). SLN detection rate per patient was 100% in both techniques. Nodal detection sensitivity was 98,5% for ferromagnetic and 93,8% for radioactive tracer. Malignancy detection rate per patient was 100% positive with both methods. Malignancy rate for nodes was 21,5% and for patients - 45%.
Conclusion We consider the new method of SLN detection with the use of ferromagnetic injection in vulvar cancer patients as reliable, safe and non inferior to the standard of care. However these promising data are few thus the SARVU study must be continued to proove the efficacy of a novel technique of Sentimag/Sienna+® use in SLN detection in vulvar carcinoma.
Disclosure The SARVU study was supported by SYSMEX Europe company in providing the ferromagnetic tracer agent and technical support. No gratification was paid to the study investigators.
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