A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva.
Histologically confirmed newly diagnosed or recurrent (local) vulva SCC with or without distant metastases within 12 months
Tumor size ≤ 7 centimeters in the longest diameter.
Targeted lesion must be technically amenable for complete coverage (including margins) by the Alpha DaRT sources.
Measurable target according to RECIST v1.1
Concomitant chemotherapy or immunotherapy within the past 4 weeks
Fit for surgical exploration unless the patient refuses surgery
Known hypersensitivity to any of the components of the treatment.
Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.