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SONODYNAMIC THERAPY IN RECURRENT HIGH-GRADE GLIOMA
About the Glioma
clinical trial
The Ivy Brain Tumor Center at Barrow Neurological Institute, a nonprofit translational research program, is conducting a Phase 0, first-in-human clinical trial of sonodynamic therapy (SDT) in ascending energy doses to assess safety and efficacy in patients with recurrent high-grade glioma.
In this study, sonodynamic therapy is the combination of the drug SONALA-001 (5-ALA, aminolevulinic acid HCl, or ALA) and a Magnetic Resonance-Guided Focused Ultrasound device called the Exablate 4000 Type-2 Device.
The goal of this study is to assess biological changes (tumor cell death) associated with the sonodynamic therapy.
Glioblastoma Trial Details
Recruiting
SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)
High-Grade Glioma
30 Participants
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You may be eligible if:
- You are 18 years or older
- You have had prior resection (surgical removal) of a histologically diagnosed high-grade glioma (III and IV)
- You have been treated with radiation and a chemotherapy drug called temozolomide
- Your doctor has told you that your tumor has recurred (come back) or has progressed (grown or changed)
How it works
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The patient will be given aminolevulinic acid HCI (ALA) using an intravenous (IV) catheter 2, 4 or 6 days prior to a planned operation to remove their tumor.
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Approximately 6-7 hours after receiving ALA, they will undergo MR-guided focused ultrasound (MRgFUS) which will apply pulses of energy to activate the drug.
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During surgery, tumor tissue samples will be collected so our team of experts can assess any biological changes (tumor cell death) associated with the sonodynamic therapy.
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We will follow up with the patient for 30 days after surgery to assess safety of the therapy.
Am I Eligible?
Submit a free trial screening request today to learn if you may qualify for any of our studies.