Alpha Tau Medical Ltd. announced that its first patient with squamous cell carcinoma of the vulva has been treated in a feasibility and safety study of Alpha DaRT at Addenbrookes Hospital of the Cambridge University Hospitals NHS Foundation Trust in Cambridge, England. The investigator-initiated trial seeks to recruit 10 participants who have newly diagnosed or locally recurrent vulva cancer with or without distant metastases. The study will assess the safety and feasibility of using the Alpha DaRT by measuring the treatment-related adverse events in the 6-month follow-up period.

In addition, the study will also examine the efficacy of Alpha DaRT in terms of tumor response at 4 weeks after Alpha DaRT insertion using RECIST criteria, historical evidence of necrosis in pathological lymph nodes (if removed) and percentage of necrotic tissue (if residual tumor is removed surgically) at 4-6 weeks, local control rate at 3-month and 6-month follow up visits, patient-rated pain score, mental state and physical state over the 6-month follow up period.