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 (FU
| Condition(s) | Recurrent Glioblastoma, Glioblastoma Multiforme, GBM |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. 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 * The brain tumor to be treated must be in the treatment envelope of the NaviFUS system (30 mm to 90 mm from the inner skull table) * Recurrence will be assessed by imaging and confirmed by consensus at tumor board 2. Men or women between the ages of 18-80 years of age at the time of consent 3. No contraindication to repeat brain surgery 4. Karnofsky Performance Score of 7 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Shayan Moosa, MD |
| Locations | Charlottesville, Virginia, United States |
| Start date | 2024-01-31 |
| NCT ID | NCT06039709 |
| Official listing | https://clinicaltrials.gov/study/NCT06039709 |