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Sonodynamic Therapy in Patients With Recurrent GBM — GBM 001  

Glioblastoma Multiforme Clinical Trial

Official title:
Pilot Study of Sonodynamic Therapy With 5-ALA for the Treatment of Recurrent Glioblastoma Using Neuronavigation-Guided Low-Intensity Focused Ultrasound

Clinical Trial Summary

Patients diagnosed with glioblastoma (GBM) are faced with limited treatment options. This pilot study will evaluate the safety and feasibility of combining an investigational drug called 5-ALA with neuronavigation-guided low-intensity focused ultrasound (LIFU) for patients who have recurrent GBM. Focused ultrasound (FUS) can be used to non-invasively destroy tumor tissue while preserving normal tissue. When FUS is combined with 5-ALA, this combinatorial approach is called sonodynamic therapy (SDT), and this investigational therapy is being tested for its ability to cause damage to GBM cells. SDT will take place prior to surgery for recurrent GBM.

Clinical Trial Description

The combination of 5-ALA (Gleolan) and LIFU is collectively known as sonodynamic therapy (SDT). SDT is an investigational therapy that will be administered 1-3 weeks before surgery for recurrent GBM. Researchers seek to determine the safety and feasibility of this therapy as well as measure its effectiveness to elicit tumor-cell death. All participants are expected to stay overnight in the hospital following administration of SDT to monitor for adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06039709
Study type Interventional
Source University of Virginia
Contact Zachary Sturgill
Phone 434-243-9986
Email FFM7RC@uvahealth.org
Status Recruiting
Phase Phase 1
Start date January 31, 2024
Completion date June 2026
View Details
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