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RecruitingPhase 1NCT06039709

Sonodynamic Therapy in Patients With Recurrent GBM

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

Sponsor

Shayan Moosa, MD

Enrollment

11 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

GBMGlioblastoma MultiformeRecurrent Glioblastoma

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called sonodynamic therapy — where ultrasound waves are used to activate a drug injected into the tumor — for patients whose glioblastoma (a very aggressive brain cancer) has come back after previous treatment. **You may be eligible if...** - You are 18–80 years old with glioblastoma that has recurred (come back) - Your tumor is in a surgically accessible area of the brain - You are well enough to undergo surgery again - Your tumor meets specific size requirements (between 2 and 20 cubic centimeters) **You may NOT be eligible if...** - You have contraindications to brain surgery - Your tumor is not in a location reachable by the treatment device - Your general health or performance level does not meet study standards - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCT5-ALA and Low-Intensity Focused Ultrasound (SDT)

5-ALA (20mg/kg orally) given \~6 hours prior to LIFU. Focused ultrasound will target a maximum of 50% of the tumor.

Locations(1)

University of Virginia

Charlottesville, Virginia, United States

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NCT06039709

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