Objectives We have 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 with radioisotope (Tc99) and gamma probe in vulvar cancer patients.
Methods 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 We found SLN in every case with both studied methods with 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%.
Conclusions 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 with a radiocoloid. 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.
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