Ultrasound device opens brain barrier to attack deadly tumors
NCT ID NCT04528680
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests an implantable ultrasound device that temporarily opens the blood-brain barrier, allowing chemotherapy to reach brain tumors. It includes 57 adults with recurrent glioblastoma who have already tried 1-2 treatments. The goal is to find a safe dose and see if this approach can shrink tumors and extend survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 57 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 years and older
- 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. Confirmed diagnosis of Isocitrate Dehydrogenase 1 (IDH1) wild-type glioblastoma on pathology from initial surgery (e.g. IDH R132H neg); morphologic or molecular determination of grade 4 2. Ability to undergo contrast-enhanced MRI 3. Radiographic evidence of tumor recurrence/progression after failure of 1 - 2 lines of prior therapy 4. Measurable or evaluable disease 1. Measurable: contrast-enhancement (bidirectional diameters ≥ 1cm) on MRI 2. Non-measurable/evaluable: contrast-enhancement diameters \< 1 cm 5. Maximal tumor diameter pre-surgery ≤ 70 mm on T1wMRI 6. Candidate for at least partial surgical resection 7. Greater 12 weeks from completion of radiation therapy 8. Age ≥ 18 years 9. If receiving dexamethasone for mass effect, a stable daily dose of dexamethasone at \< 6 mg within 7 days of registration, or if dexamethasone dose is decreasing, average daily dose of \< 6 mg in the 7 days prior to registration. Patients on dexamethasone for reasons other than mass effect may still be enrolled. 10. WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) of ≥70) 11. Adequate hepatic, renal and bone marrow function, documented with normal laboratory values or no more than grade 1 outside the norm performed within 14 days prior to registration 12. For patients with a childbearing potential 1. Negative pregnancy test within 14 days prior to registration 2. Agreement to use adequate contraception for the duration of study participation, and for 3 and 6 months after the last dose of albumin-bound paclitaxel for men and women of childbearing potential, respectively. 13. Have the ability to understand and the willingness to sign a written informed consent prior to registration on study 14. Be willing and able to comply with the protocol for the duration of the study 15. Provide written, signed and dated informed consent prior to study registration. NOTE: no study-specific screening procedures may be performed until written consent has been obtained Exclusion Criteria: 1. Have multifocal disease that cannot be encompassed in the ultrasound fields: 1. e.g. \> 70-mm apart 2. tumor located in the posterior fossa 2. Patients at risk of cranial wound dehiscence 3. Have uncontrolled epilepsy or require treatment with enzyme-inducing antiepileptics 4. Have clinical evidence of peripheral neuropathy on examination 5. Have received any other investigational agents within 4 weeks of registration 6. Have received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin 7. Medical contraindications to Abraxane® or carboplatin 8. Have an uncontrolled intercurrent illness 9. Are pregnant or nursing 10. Have a history of active malignancy within 3 years prior to registration. 11. Have a known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Definity® (the FDA-approved ultrasound contrast agent to be used in this study) 12. Patients with coils, clips, shunts, intravascular stents, and/or non-removable wafer, non resorbable dura substitute, or reservoirs. 13. Patients with medical need to continue antiplatelet therapy. 14. Patients with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome (patient at risk for microbubble reaction). 15. Patients with impaired thermo-regulation or temperature sensation (due to device)
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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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Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
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Other studies related to the condition(s) this trial covers.
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