Sound waves may crack open the Brain's shield to deliver chemo
NCT ID NCT02343991
First seen Oct 19, 2026 · Last updated Oct 20, 2026 · Updated 1 time
Summary
Researchers are testing whether focused ultrasound guided by MRI can safely open the blood-brain barrier in people with brain tumors. The barrier normally protects the brain but also blocks many drugs from reaching tumors. In this small study, participants receive an intravenous ultrasound contrast agent while ultrasound waves are aimed at the tumor to temporarily disrupt the barrier. The goal is to see whether this approach safely allows more of the chemotherapy drug doxorubicin to reach the tumor and nearby brain tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MRI-guided focused ultrasound with an ultrasound contrast agent to open the blood-brain barrier so doxorubicin can reach brain tumors
- What this could lead to
- If it works, this approach could give doctors a way to push chemotherapy drugs past the blood-brain barrier and into brain tumors, which may improve treatment for a cancer that is hard to reach.
- What could go wrong
- This is a very small early safety study with only a handful of participants, so it cannot show whether the treatment helps patients. Opening the blood-brain barrier also carries risks such as bleeding, swelling, or infection in the brain.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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5 people
The number who actually took part.
- Started
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Oct 2014
- Finished
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Oct 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men or women. * Age between 18 and 70 years, inclusive. * Able and willing to give informed consent. * Size of the targeted portion of the tumour (i.e. prescribed ROT) is less than 2.5 cm in diameter (16 cm3). The non-targeted tumour tissue may exceed the targeted volume. * Karnofsky rating 70-100 * ASA score 1-3. * Able to communicate sensations during the ExAblate MRgFUS procedure. * Able to attend all study visits (i.e., life expectancy of at least 3 months). * At least 14 days passed since last brain surgery. Exclusion Criteria: * The sonication pathway to the tumour involves: i. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp ii. Clips or other metallic implanted objects in the skull or the brain, except shunts * The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema) * Cardiac disease or unstable hemodynamics including: i. Documented myocardial infarction within six months of enrolment ii. Unstable angina on medication iii. Congestive heart failure iv. Left ventricular ejection fraction below the lower limit of normal v. History of a hemodynamically unstable cardiac arrythmia vi. Cardiac pacemaker * Severe hypertension (diastolic BP \> 100 on medication) * Anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g.:ASA, non-steroidal anti-inflammatory drugs (NSAIDs), statins) * History of a bleeding disorder, coagulopathy or with a history of spontaneous tumour hemorrhage * Abnormal level of platelets (\< 100000), PT (\>14) or PTT (\>36), and INR \> 1.3 * Documented cerebral infarction within the past 12 months * TIA in the last 1 month * Cerebral or systemic vasculopathy * Insulin-dependent diabetes mellitus * Immunosuppression (corticosteroids to prevent/treat brain edema are permitted) * Known sensitivity to gadolinium-DTPA * Contraindications to MRI such as non-MRI-compatible implanted devices * Large subjects not fitting comfortably into the MRI scanner (generally \>250 lbs) * Difficulty lying supine and still for up to 4 hours in the MRI unit or claustrophobia * Untreated, uncontrolled sleep apnea * Positive pregnancy test (for pre-menopausal women) * Known life-threatening systemic disease * Severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2 and/or on dialysis * Right to left or bi-directional cardiac shunt * Previous full course of doxorubicin chemotherapy * Allergy to eggs or egg products
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
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