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Sound waves could make brain tumor diagnosis safer and smarter

NCT ID NCT04940507

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial explores whether focused ultrasound can enhance the release of tumor DNA into the blood and spinal fluid, potentially making liquid biopsies a more reliable way to diagnose brain tumors. Researchers will use MRI-guided focused ultrasound to partially ablate the tumor in about 50 adults with new brain lesions, then collect blood and cerebrospinal fluid samples before and after the procedure. The goal is to see if this approach increases the amount of tumor DNA in circulation and improves the accuracy of molecular subtyping, which could reduce the need for invasive surgical biopsies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Magnetic Resonance-guided Focused Ultrasound (MRgFUS) used to partially ablate brain tumors and enhance liquid biopsy
What this could lead to
If successful, this could make brain tumor diagnosis less invasive and more accurate, potentially reducing the need for risky surgical biopsies.
What could go wrong
This is an early feasibility study with a small number of participants. The technique may not reliably boost tumor DNA levels, and the procedure carries risks like bleeding or neurological complications.

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

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

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: * New MRI-diagnosed intracranial lesions that are suitable to biopsy surgically * The lesion to be treated is clearly defined and can be well distinguished from surrounding brain tissue. * Male or female aged 18 years or older * Capable of providing informed consent and complying with study procedures, including tolerability in the supine position and MRI examination without significant claustrophobia, and acceptance of surgery (open or stereotactic) after HIFU treatment. * Able to communicate during the ExAblate® MRgFUS procedure. * Karnofsky rating 70-100 Exclusion Criteria: * If region of treatment locates in \< 1.0 cm from the inner table of the skull, on skull base or in the posterior fossa * Presence of hydrocephalus, severe vomiting, intractable headache or decreased level of consciousness due to increased intracranial pressure * Unable to complete high-density CT and MRI studies of the head at the any other MRI contraindication, such as: * Large body habitus and not fitting comfortably into the scanner * Difficulty lying supine and still for up to 2 in the MRI unit or significant claustrophobia * MRI findings: * Active infection/inflammation * Acute or chronic brain haemorrhages * Moderate/severe brain edema or midline shift \>15 mm * Clips or other metallic implanted objects in the skull or the brain, except shunts * Significant cardiac disease or unstable hemodynamic status. * On medications that increase the bleeding risk, specifically: a) aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abciximab) for the last 7 days prior to treatment; b) oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours, and intravenous or subcutaneous heparin-derived compounds for the last 48 hours * Abnormal coagulation profile, specifically: platelet \<100,000/μl, Prothrombin Time \>14 seconds, activated partial thromboplastin time (aPTT) \>36 seconds, and INR \> 1.3 * Unqualified fit for the anaesthesia by an anesthesiologist assessment, ASA IV-V. * Currently in a clinical trial involving an investigational product or non-approved use of a drug or device. * Pregnant and lactating women

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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

  • Toronto Western Hospital, University Health Network

    Toronto, Ontario, M5T 2S8, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.