Sonodynamic Therapy in Patients With Recurrent GBM

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. S

Trial Details

NCT ID
NCT06039709
Phase
PHASE1
Sponsor
Shayan Moosa, MD
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • 5-ALA and Low-Intensity Focused Ultrasound (SDT)
Locations (sample)
  • Charlottesville, Virginia, United States|38.02931,-78.47668

Key Eligibility Criteria

  • Disease status and Disease Parameters:
  • Suspected recurrent glioblastoma that is clearly measurable based on the modified Response Assessment in Neuro-Oncology (RANO) criteria
  • The tumor lesion needs to comprise at least 1 contrast-enhancing lesion with a volume of ≥ 2 cm3 and ≤ 20 cm3 of targeted treatment area
  • Tumor tissue to be treated is in a surgically accessible brain region for resection

For full eligibility, visit ClinicalTrials.gov.

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