A Pilot Study to Evaluate the Safety and Feasibility of Sonodynamic Therapy Using the ExAblate MRI-Guided Focused Ultrasound in the Treatment of Cerebral Glioblastomas.

Detailed Summary

The goal of this prospective, non-randomized, single-arm study is to evaluate the safety and feasibility of sonodynamic therapy with 5-aminolevulinic acid in patients with newly diagnosed cerebral glioblastomas using the ExAblate Model 4000 Type-2 "Neuro-System". Patients will be consented, screened, and will undergo study SDT treatment with 5-ALA using the ExAblate Model 4000 Type-2 "Neuro-System". After SDT treatment, patients will perform a strict neuro-radiological follow-up (minimum of 2 MRI) and undergo tumor resection 15-21 days after SDT, according to the clinical and radiological status. The main goal of the present study is to investigate the safety and feasibility of SDT in patients affected by GBMs attained with low-frequency FUS. In particular: Safety will be evaluated by patient examination and MRI images during the treatment, and by follow-up MRI and clinical and neurological visits. To evaluate feasibility, the extent of the sonicated area will be calculated at the end of the procedure in order to evaluate the targeted area. Secondary objective of the trial is to assess the efficacy of the SDT procedure in terms of tumor regression and/or cell apoptosis and necrosis.

Study Details

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Interventions