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Sound waves open brain's shield to attack deadly tumors

NCT ID NCT04440358

Disease control Sponsor: InSightec Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested whether a focused ultrasound device can safely open the blood-brain barrier in 13 adults with recurrent glioblastoma, a severe brain cancer. The goal was to let the chemotherapy drug carboplatin reach the tumor more effectively. The study focused on safety and whether the barrier could be opened, not on curing the disease.

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

13 people

The number who actually took part.

Started

Oct 2020

Finished

Dec 2023

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

18 to 80 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must be between 18-80 years old * Histologically confirmed glioblastoma * Planned for Carboplatin monotherapy * Be willing and able to provided written informed consent/assent * Tumor progression after first line therapy * Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy * Women of childbearing potential is confirmed not pregnant. Male and Female subjects utilize highly effective contraception * Able to communicate verbally Exclusion Criteria: * Acute intracranial hemorrhage * Ferrous metallic implanted objects in the skull or brain * Prior toxicity with carboplatin chemotherapy * Women who are pregnant or breastfeeding * Cerebellar spinal cord or brain stem tumor * Known active Hepatitis B or Hepatitis C or HIV * Significant depression not adequately controlled * Cardiac disease or unstable hemodynamics * Severe hypertension * History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage * Active drug or alcohol use disorder * Known sensitivity to gadolinium-based contrast agents * Known sensitivity or contraindications to ultrasound contrast agent or perflutren * Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted devices * Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication * Severely impaired renal function * Right to left or bi-directional cardiac shunt * Cranial or systemic infection requiring antibiotics * Known additional malignancy that is progression or require active treatment

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Conditions

The condition(s) this trial relates to.

glioblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent glioblastoma

Contacts and locations

Locations

  • Fondazione IRCCS Neurologico Carlo Besta

    Milan, 20133, Italy

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Yonsei University Medical Center

    Seoul, 120-752, South Korea

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