Actively Recruiting
Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy
Led by Sunnybrook Health Sciences Centre · Updated on 2025-09-17
10
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety and feasibility of focused ultrasound (FUS)-mediated blood-brain barrier (BBB) disruption using the Next Generation Dome Helmet (NGDH) in adults with glioblastoma (GBM) undergoing the maintenance phase of the standard "Stupp protocol". Participants will: * Undergo repeated FUS BBB disruption treatments during the maintenance phase of temozolomide (TMZ) chemotherapy. * Receive intravenous ultrasound contrast (DEFINITY®) prior to each FUS session to facilitate targeted BBB disruption. * Undergo serial MRI scans and clinical assessments to evaluate safety and the extent of BBB opening. * Provide blood samples (and tumor tissue if available) for biomarker analysis related to BBB permeability, tumor presence, and treatment response. * Be followed for progression-free survival (PFS) and overall survival (OS) during routine neuro-oncology visits until end of life.
CONDITIONS
Official Title
Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years, inclusive.
- Able and willing to provide written informed consent.
- Diagnosis of Glioblastoma by histology or molecular markers based on WHO 2021 classification.
- Previously undergone a maximal safe surgical resection and completed concurrent, standard-of-care RT and TMZ without complications and eligible for maintenance TMZ treatment.
- Tumor or resection cavity clearly defined on screening MRI.
- Karnofsky Performance Score of 70-100.
- American Society of Anesthesiologists (ASA) physical status score of 1-3.
- Life expectancy of at least 3 months and able to attend all study visits.
You will not qualify if you...
- Brain edema or mass effect causing midline shift or shift in wall of third ventricle >10 mm after steroid treatment.
- Recent (less than 2 weeks) intracranial hemorrhage.
- Calcifications in the ultrasound beam path that cannot be worked around.
- More than 30% of skull area in sonication path covered by scars, scalp disorders, or scalp atrophy.
- Clips or metallic implants in skull or brain, except shunts.
- Symptoms of increased intracranial pressure (headache, nausea, vomiting, lethargy, papilledema).
- Increasing doses of corticosteroids required.
- Receiving bevacizumab (Avastin) therapy.
- Greater than or equal to 25% increase in contrast enhancement volume compared to first postoperative MRI.
- Undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins, gene/viral therapies, immunotherapies, or focal irradiation.
- Cardiac disease or unstable hemodynamics including recent myocardial infarction, unstable angina, congestive heart failure, low ejection fraction, unstable arrhythmia, or pacemaker.
- Severe hypertension (diastolic BP > 100 on medication).
- Use of anticoagulants or medications increasing hemorrhage risk within specified washout periods.
- History of bleeding disorder, coagulopathy, or spontaneous tumor hemorrhage.
- Abnormal platelet count (<100,000) or INR > 1.3.
- Recent cerebral infarction or TIA.
- Cerebral or systemic vasculopathy.
- Uncontrolled insulin-dependent diabetes.
- Known sensitivity to gadolinium-DTPA or DEFINITY® contrast agent.
- Contraindications to MRI or inability to tolerate MRI.
- Positive pregnancy test.
- Known life-threatening systemic disease.
- Severely impaired renal function or dialysis.
- Cardiac shunts.
- Prior full chemotherapy or radiotherapy for GBM.
- Allergy to eggs or egg products.
- Cranial or systemic infection.
- Chronic pulmonary disorders.
- History of drug allergies, asthma, hay fever, multiple allergies, or anaphylaxis.
- Family or personal history of QT prolongation or taking QT prolonging medications.
- Evidence of Hepatitis B infection/carrier state.
- Liver injury preventing study participation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
N
Nir Lipsman, MD, PhD, FRCSC
CONTACT
M
Maheleth Llinas
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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