A dose escalation and expansion study of sonodynamic therapy with SONALA-001 in combination with Exablate 4000 Type-2 MR-guided focused ultrasound in patients with recurrent or progressive glioblastoma multiforme

Brief description of study

This is a study testing a new non-invasive treatment called sonodynamic therapy (SDT) for recurrent or progressive glioblastoma (GBM). The study team will use intravenous (IV) infusion of 5-aminolevulinic acid (5-ALA) along with MR-Guided focused to treat tumors non-invasively. The treatment will be repeated every 4 weeks. The Phase 1 portion of the study is intended to measure safety and will identify to maximum tolerated dose of 5-ALA and focused ultrasound energy. After that, the study will include more patients in Phase 2 to learn more about the efficacy of the treatment. The main goals are to check if SDT is safe for patients and if it can help patients with recurrent/progressive GBM live longer.


Clinical Study Identifier: s22-00569
ClinicalTrials.gov Identifier: NCT05370508
Principal Investigator: Dimitris G Placantonakis.
Other Investigators: Alon Mogilner, Douglas S. Kondziolka, Marissa Barbaro, Maria Del Pilar Guillermo Prieto Eibl, Timothy Michael Shepherd.


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