Actively Recruiting
Sonodynamic Therapy in Patients With Recurrent GBM
Led by Shayan Moosa, MD · Updated on 2026-04-28
11
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sonodynamic Therapy in Patients With Recurrent GBM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected recurrent glioblastoma measurable by modified RANO criteria
- Tumor lesion volume between 2 cm3 and 20 cm3 in a surgically accessible brain region
- Tumor must be within the NaviFUS system treatment area (30 to 90 mm from inner skull)
- Age between 18 and 80 years at time of consent
- No contraindications to repeat brain surgery
- Karnofsky Performance Score between 70 and 100
- Able to undergo MRI with contrast
- Able to swallow oral medications
- Willing and able to comply with study visits, treatments, and procedures
- Able to understand and willing to sign informed consent
- Prior therapies recovered to CTCAE Grade 1 or baseline, except residual alopecia or Grade 2 peripheral neuropathy
- Adequate bone marrow and organ function as defined by laboratory criteria
You will not qualify if you...
- Known allergy or sensitivity to 5-ALA
- Use of other phototoxic substances
- Diagnosis of porphyria or hypersensitivity to porphyrins
- Pregnancy
- Significant cardiac disease or blood clotting disorders
- Urgent need for brain surgery due to herniation or seizures
- Active systemic bacterial, fungal, or viral infection
- Recent (within 3 months) stroke or transient ischemic attack
- Significant vascular disease or bleeding disorders
- Need for anticoagulation that cannot be stopped 7 days before SDT
- Unstable angina or severe heart failure within 6 months
- Severe hypertension despite medication
- Recent heart attack or serious arrhythmia
- Acute worsening of chronic lung disease
- Serious uncontrolled medical conditions
- Recent investigational drug use within 30 days or 5 half-lives
- Brain edema or mass effect causing midline shift over 15 mm
- Recent intracranial hemorrhage within 30 days
- Calcifications or metal implants in ultrasound path
- Scalp atrophy or scars at transducer site
- Cerebral or systemic blood vessel disease
- Need for or current dialysis
- Chronic severe pulmonary disorders
- Radiotherapy within 21 days prior to registration
- Chemotherapy within 21 days prior to registration
- Prior sonodynamic therapy
- Concurrent use of Optune device
- Use of supplements or medications with strong antioxidant effects
- Known sensitivity to gadolinium
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
Z
Zachary Sturgill
CONTACT
J
Judith Beenhakker, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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