Sound waves help chemo reach brain tumors in early trial
NCT ID NCT04998864
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small study tested whether a device using focused ultrasound can safely open the blood-brain barrier in patients with high-grade glioma (a type of aggressive brain cancer). The goal was to allow standard chemotherapy to reach the tumor more effectively. Only 3 patients were enrolled, and the study focused on safety and whether the barrier could be opened repeatedly. This is not a cure, but a way to improve existing treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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3 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Oct 2023
- 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.
Who is studied
Patients with glioblastoma brain tumor who will undergo surgical resection and chemotherapy as standard of care with temozolomide.
- Ages
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18 to 80 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: 1. Patient is eligible for adjuvant TMZ treatment. 2. Men or women age between 18 and 80 years, inclusive. 3. Able and willing to give informed consent. 4. Grade IV glioma (GBM) confirmed Subjects 5. Karnofsky rating 70-100. 6. Able to communicate during the Exablate BBBD procedure. 7. Life expectancy of at least 3 months. Exclusion Criteria: 1. Evidence of acute intracranial hemorrhage. 2. The subject presents with severe symptoms and signs of increased intracranial pressure 3. Patients with cerebellar or brainstem tumors. 4. Patients with positive HIV status 5. Patients with brain tumors containing 1p/19q chromosomal co-deletion 6. Patient receiving bevacizumab (Avastin) therapy 7. Patients undergoing other concurrent therapies 8. Cardiac disease or unstable hemodynamics 9. Severe hypertension 10. Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment 11. History of a bleeding disorder and/or coagulopathy 12. Known sensitivity to gadolinium-based contrast agents 13. Known sensitivity to ultrasound contrast agent 14. Severely impaired renal function 15. Subjects with significant liver dysfunction
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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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CINAC-Hospital HM Puerta del Sur
Móstoles, Madrid, 28938, Spain
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Fondazione IRCCS Neurologico Carlo Besta
Milan, 20133, Italy
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Other studies related to the condition(s) this trial covers.
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