Actively Recruiting
Assessment of Safety and Feasibility of Focused Ultrasound Next Generation Dome Helmet Mediated Blood-Brain Barrier Disruption for High-Grade Glioma Treatment During Standard Chemotherapy
Led by Sunnybrook Health Sciences Centre · Updated on 2025-09-17
10
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of using focused ultrasound (FUS) with the Next Generation Dome Helmet (NGDH) to temporarily open the blood-brain barrier (BBB) in adults with glioblastoma who are undergoing the maintenance phase of standard chemotherapy with temozolomide (TMZ). This Phase I clinical trial is designed to study how this non-invasive device can assist in targeted drug delivery by disrupting the BBB, potentially improving treatment outcomes for this aggressive brain tumor. Participants in this single-arm study will receive up to six FUS BBB disruption sessions spaced 4 to 6 weeks apart while continuing their standard TMZ chemotherapy. Before each FUS session, they will receive an intravenous injection of DEFINITY® ultrasound contrast agent to help open the BBB in a targeted way. MRI will guide each treatment and assess how much the BBB opens. Alongside these treatments, clinical evaluations and blood sampling will be done regularly to study the effects of BBB disruption. During the study, participants will undergo regular MRI scans and clinical assessments to monitor safety and the extent of BBB opening. Blood samples and, if available, tumor tissue will be collected to analyze biomarkers related to treatment response. Safety evaluations will happen at baseline, then every 8 weeks during the first year and every 12 weeks in the second year, with participants also being followed for progression-free and overall survival at routine neuro-oncology visits until the end of life. The active treatment phase lasts about 6 to 8 months, with ongoing data collected as long as possible.
CONDITIONS
Brief 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
- Completed maximal safe surgical resection and concurrent radiation and temozolomide chemotherapy without complications
- Clearly defined tumor or tumor resection cavity on screening MRI scans
- Karnofsky Performance Score of 70 to 100
- American Society of Anesthesiologists (ASA) physical status score of 1 to 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 over 10 mm after steroid treatment
- Recent intracranial hemorrhage within 2 weeks prior to enrollment
- Calcifications in the focused ultrasound treatment path that cannot be avoided
- Sonication pathway with over 30% skull area affected by scars, scalp disorders, or atrophy
- Presence of clips or metallic implants in skull or brain (except shunts)
- Signs or symptoms of increased intracranial pressure
- Need for increasing corticosteroid doses
- Receiving bevacizumab (Avastin) therapy
- Over 25% increase in contrast enhancement volume compared to first postoperative MRI
- Receiving other concurrent therapies like chemotherapy wafers, immunotoxins, gene or viral therapies, immunotherapies, or focal irradiation
- Cardiac disease or unstable heart conditions including recent myocardial infarction, unstable angina, congestive heart failure, low ejection fraction, arrhythmias, or pacemaker
- Severe hypertension with diastolic blood pressure over 100 despite medication
- Use of anticoagulant medications increasing bleeding risk within specified washout periods
- History of bleeding disorders or spontaneous tumor hemorrhage
- Low platelet count or abnormal clotting tests
- Recent cerebral infarction or transient ischemic attack
- Cerebral or systemic vascular disease
- Poorly controlled insulin-dependent diabetes
- Known sensitivity to gadolinium-DTPA or DEFINITY® contrast agent
- Contraindications to MRI such as incompatible implants, intolerance, or untreated sleep apnea
- Positive pregnancy test for pre-menopausal women
- Life-threatening systemic diseases
- Severe kidney impairment or dialysis
- Cardiac shunts
- Previous full chemotherapy or radiotherapy for glioblastoma
- Allergy to eggs or egg products
- Evidence of 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 medications causing QT prolongation
- Hepatitis B infection or carrier status
- Liver injury preventing study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 8 months
Participants undergo up to 6 cycles of focused ultrasound-mediated blood-brain barrier disruption using the Next Generation Dome Helmet during the maintenance phase of standard temozolomide chemotherapy. Each session includes an MRI-guided procedure with intravenous injection of DEFINITY® ultrasound contrast agent to enable targeted BBB opening. Clinical and safety assessments, blood sampling, and imaging are conducted during this period.
Up to 6 treatment sessions spaced 4 to 6 weeks apart
Duration - Up to 2 years or longer as possible
Participants are monitored to evaluate safety, clinical efficacy, and biomarker changes after treatment. Assessments include clinical evaluations and imaging at baseline, every 8 weeks during the first year, and every 12 weeks during the second year, continuing as long as possible.
Visits every 8 weeks during the first year, then every 12 weeks during the second year
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
M
Maheleth Llinas
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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