Sonodynamic Therapy With ExAblate System in Glioblastoma Patients

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.

Timeline

Start

2023-02-22

Primary completion

2024-10-30

Completion

2024-10-30

Publications

• Results Bonosi L, Marino S, Benigno UE, Musso S, Buscemi F, Giardina K, Gerardi R, Brunasso L, Costanzo R, Iacopino DG, Maugeri R. Sonodynamic therapy and magnetic resonance-guided focused ultrasound: new therapeutic strategy in glioblastoma. J Neurooncol. 2023 May;163(1):219-238. doi: 10.1007/s11060-023-04333-3. Epub 2023 May 14.
• Results Pellegatta S, Corradino N, Zingarelli M, Porto E, Gionso M, Berlendis A, Durando G, Maffezzini M, Musio S, Aquino D, DiMeco F, Prada F. The Immunomodulatory Effects of Fluorescein-Mediated Sonodynamic Treatment Lead to Systemic and Intratumoral Depletion of Myeloid-Derived Suppressor Cells in a Preclinical Malignant Glioma Model. Cancers (Basel). 2024 Feb 15;16(4):792. doi: 10.3390/cancers16040792.
• Results Keating GF, Chesney KM, Patel N, Kilburn L, Fonseca A, Packer RJ, Challa C, O'Brien PF, Donoho DA, Myseros JS, Oluigbo C, Keating RF, Syed HR. MR-guided focused ultrasound in pediatric neurosurgery: current insights, technical challenges, and lessons learned from 45 treatments at Children's National Hospital. Neurosurg Focus. 2024 Sep 1;57(3):E6. doi: 10.3171/2024.6.FOCUS24332.
• Results Huangfu L, Zha B, Li P, Wang L, Liu X, Cui H, Li Y, Wu J, Shi S, Yang Y, Sun X, Gao S, Li H, Yang D, Zheng Y. A phase I clinical trial of sonodynamic therapy combined with radiotherapy for brainstem gliomas. Int J Cancer. 2025 Mar 1;156(5):1005-1014. doi: 10.1002/ijc.35218. Epub 2024 Oct 8.

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Indications