Sound waves open brain barrier to attack deadly childhood tumor
NCT ID NCT05615623
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether focused ultrasound can temporarily open the blood-brain barrier in children with a rare, aggressive brain tumor called DIPG. The goal is to let the chemotherapy drug doxorubicin reach the tumor more effectively. Only 10 children aged 5 to 18 will take part, and the main focus is on safety and feasibility, not yet on curing the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- doxorubicin (a chemotherapy drug)
- What this could lead to
- If it works, this could offer a new way to deliver chemotherapy directly to hard-to-treat brain tumors in children, potentially improving outcomes for DIPG.
- What could go wrong
- This is a very early, small trial (10 children) focused on safety. The approach is experimental, may not shrink tumors, and carries risks from both the ultrasound procedure and chemotherapy side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2023
- Expected to finish
-
Oct 2026
An estimate. End dates often move.
- Lead sponsor
-
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
-
5 to 18 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Age between 5 and 18 years, inclusive * Patient diagnosed with DIPG * At least 4-week and not greater than 12 weeks from completion of radiation therapy * Post-radiation imaging does not show evidence of necrosis/ hemorrhage or other features that contraindicate MRgFUS * Able to attend all study visits and with life expectancy of at least 6 months * Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so * If on steroids, stable or decreasing dose for at least 7 days prior to study entry * If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable Exclusion Criteria: * Evidence of cranial or systemic infection * Known life-threatening systemic disease * Previous treatment with complete cumulative doses of Doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones * Contraindication to Doxorubicin. - Known sensitivity to DEFINITY® ultrasound contrast agent or known hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol. - Known sensitivity to gadolinium-based contrast agents * Active seizure disorder or epilepsy (seizures despite medical treatment) for a minimum of 4 weeks prior to first cycle/Exablate BBBD procedure captured by history * Patients with positive HIV status. - Immunosuppression (corticosteroids to prevent/treat brain edema are permitted) * Cerebral or systemic vasculopathy, including intracranial thrombosis, vascular malformation, cerebral aneurysm, or vasculitis * Hypertension per age * History of a bleeding disorder, coagulopathy or with a history of spontaneous tumour hemorrhage * Anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g., ASA, non-steroidal anti-inflammatory drugs \[NSAIDs\], statins) within washout period prior to treatment * Patient receiving bevacizumab (Avastin) therapy or increasing doses of steroids * Symptoms and signs of increased intracranial pressure * Previous participation in other chemotherapy, molecularly targeted therapy or immunotherapy treatment-related phase 1 or 2 trials * Tumor not visible on any pre-therapy or post-radiation imaging
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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
-
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
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