Sonodynamic Therapy in Patients With Recurrent GBM (NCT06039709)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (24 items) and avoid the listed exclusions (33 items).
Location: University of Virginia — Charlottesville, Virginia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Known sensitivity or allergy to 5-ALA
- Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
- Diagnosis of porphyria
- Hypersensitivity against porphyrins
- Pregnancy
- Significant cardiac disease or coagulopathy
- Herniation / intractable seizure / other clinical indications requiring urgent resection
- Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive)
- Have had a recent (≤3 months prior to registration) transient ischemic attack or stroke
- Significant vascular disease (e.g. aortic aneurysm)
- Evidence of bleeding diathesis or coagulopathy
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Virginia — Charlottesville, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.