Intracranial Sonodynamic Therapy With 5-Aminolevulinic Acid and Sodium Fluorescein: Safety Study in a Porcine Model

Author:

Raspagliesi Luca,D’Ammando Antonio,Gionso Matteo,Sheybani Natasha D.,Lopes Maria-Beatriz,Moore David,Allen Steven,Gatesman Jeremy,Porto Edoardo,Timbie Kelsie,Franzini Andrea,Di Meco Francesco,Sheehan Jason,Xu Zhiyuan,Prada Francesco

Abstract

BackgroundSonodynamic therapy (SDT) is an emerging ultrasound-based treatment modality for malignant gliomas which combines ultrasound with sonosensitizers to produce a localized cytotoxic and modulatory effect. Tumor-specificity of the treatment is achieved by the selective extravasation and accumulation of sonosensitizers in the tumor-bearing regions. The aim of this study is to demonstrate the safety of low-intensity ultrasonic irradiation of healthy brain tissue after the administration of FDA-approved sonosensitizers used for SDT in experimental studies in an in vivo large animal model.MethodsIn vivo safety of fluorescein (Na-Fl)- and 5 aminolevulinic acid (5-ALA)-mediated low-intensity ultrasound irradiation of healthy brain parenchyma was assessed in two sets of four healthy swine brains, using the magnetic resonance imaging (MRI)-guided Insightec ExAblate 4000 220 kHz system. After administration of the sonosensitizers, a wide fronto-parietal craniotomy was performed in pig skulls to allow transmission of ultrasonic beams. Sonication was performed on different spots within the thalamus and periventricular white matter with continuous thermal monitoring. Sonication-related effects were investigated with MRI and histological analysis.ResultsPost-treatment MRI images acquired within one hour following the last sonication, on day one, and day seven did not visualize any sign of brain damage. On histopathology, no signs of necrosis or apoptosis attributable to the ultrasonic treatments were shown in target areas.ConclusionsThe results of the present study suggest that either Na-FL or 5-ALA-mediated sonodynamic therapies under MRI-guidance with the current acoustic parameters are safe towards healthy brain tissue in a large in vivo model. These results further support growing interest in clinical translation of sonodynamic therapy for intracranial gliomas and other brain tumors.

Funder

Focused Ultrasound Foundation

Publisher

Frontiers Media SA

Subject

Cancer Research,Oncology

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1. Sonodynamic therapy for adult-type diffuse gliomas: past, present, and future;Journal of Neuro-Oncology;2024-07-23

2. Microbubble-Enhanced Focused Ultrasound for Infiltrating Gliomas;Biomedicines;2024-06-01

3. Focused ultrasound as a treatment modality for gliomas;Frontiers in Neurology;2024-05-15

4. Strategies to Improve Drug Delivery Across the Blood–Brain Barrier for Glioblastoma;Current Neurology and Neuroscience Reports;2024-04-05

5. Glioblastoma Therapy: Past, Present and Future;International Journal of Molecular Sciences;2024-02-21

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