drugset / Trial / NCT06039709

Sonodynamic Therapy in Patients With Recurrent GBM

NCT06039709

Phase 1 Recruiting 11 enrolled Shayan Moosa, MD
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-01-31
Primary completion
2026-12
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Aminolevulinic Acid Diagnostic / imaging agent 20 mg/kg Oral

Indications