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GliomaNCT03322813

ExAblate Blood Brain Barrier Disruption (BBBD) for Planned Surgery in Suspected Infiltrating Glioma

A study testing ExAblate 4000 - Type 2 in people with Glioma, run by InSightec at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This study is designed to assess the safety and feasibility of using the ExAblate, Type 2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma. The ExAblate Model 4000 Type-2 is intended for use as a tool to disrupt the BBB. Read more about this study

Who is it for?
Ages 21 to 85 years
Conditions the study is for
Glioma
What is being tested?
ExAblate 4000 - Type 2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Oct 2023to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or Female between 21-85 years of age
  • Able and willing to give informed consent
  • Subjects with suspected infiltrating glioma on pre-operative brain imaging scans including non-enhancing MRI tumor components in non-eloquent regions that are within the planned surgical resection volume
  • Surgical area targeted for ExAblate treatment (i.e. prescribed Region of Treatment) ≤30 cm3; planned surgical resection volume may exceed the targeted treatment volume
  • Karnofsky Performance Score 70-100
  • Able to communicate sensations during the ExAblate® BBBD procedure

Who cannot join

  • MRI or clinical findings of:
  • Active or chronic infection(s) or inflammatory processes
  • Acute or chronic hemorrhages, specifically any lobar microbleeds, and no siderosis, amyloid angiopathy, or macrohemorrhages
  • Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis
  • Evidence of tumor-related calcification, cyst, or hemorrhage
  • Midline shift of >10mm or evidence of subfalcine, uncal, or tonsillar herniation on pre-operative imaging
Show all 30Show fewer
  • More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
  • Clips, shunts, or any metallic implanted objects in the skull or the brain or the presence of unknown MR unsafe devices anywhere within the body
  • Significant cardiac disease or unstable hemodynamic status
  • Uncontrolled hypertension (systolic > 150 and diastolic BP > 100 on medication)
  • Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk of hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
  • History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage
  • Abnormal coagulation profile (Platelets < 100,000), PT (>14) or PTT (>36), and INR > 1.3
  • Lacunar lesions or evidence of increased risk of bleeding
  • Known cerebral or systemic vasculopathy
  • Significant depression and at potential risk of suicide
  • Known sensitivity/allergy to gadolinium, or other intravascular contrast agents
  • Active seizures despite medication treatment (defined as >1 seizure per month) which could be worsened by disruption of the blood brain barrier
  • Evidence of worsening neurological function
  • Dexamethasone dose ≥ 24mg daily or equivalent steroid dose
  • History of drug or alcohol disorder which have a higher risk for seizures, infection and/or poor executive functioning
  • Positive HIV status, which can lead to increased entry of HIV into the brain parenchyma leading to HIV encephalitis
  • Potential blood-borne infections which can lead to increased entry to brain parenchyma leading to meningitis or brain abscess
  • Any contraindications to MRI scanning, including:
  • Large subjects not fitting comfortably into the scanner
  • Difficulty lying supine and still for up to 3 hours in the MRI unit or claustrophobia
  • Untreated, uncontrolled sleep apnea
  • Impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2
  • Respiratory: chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area, patients with a history of drug allergies, asthma or hay fever, and multiple allergies where the benefit/risk of administering Definity® is considered unfavorable by the study physicians in relation to the product labeling for Definity
  • Currently in a clinical trial involving an investigational product or non-approved use of a drug or device

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Maryland Medical System

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Study to Evaluate the Safety and Feasibility of Exablate Model 4000 Type-2 to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) in Patients With Suspected Infiltrating Glioma in the Setting of Planned Surgical Interventions

This study is designed to assess the safety and feasibility of using the ExAblate, Type 2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma. The ExAblate Model 4000 Type-2 is intended for use as a tool to disrupt the BBB.

Read the detailed description

This study is a prospective, single-arm, non-randomized, open-label feasibility study to evaluate the safety of focal BBBD using the ExAblate® 4000 Type 2 system. Up to 15 subjects with suspected infiltrating glioma who are scheduled to undergo brain tumor resection may be recruited for the study. Only patients that have a non-enhancing tumor components in a non-eloquent region of the planned standard-of-care resection volume will be eligible. Up to 4 centers may participate in this study.

Conditions
Glioma
Being tested
ExAblate 4000 - Type 2
Keywords
Glioblastoma, Blood Brain Barrier, BBB, ExAblate, Blood Brain Barrier Disruption, Infiltrating glioma
Medical subject headings
Glioma, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExAblate 4000 - Type 2Device

    Also called ExAblate BBBD

    Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma undergoing resection

Study groups in NCT03322813
Study groupRoleWhat they receive
ExAblate 4000 - Type 2ExperimentalExAblate BBBD
Receives: Device: ExAblate 4000 - Type 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device and procedure related adverse events

    The number and severity of device and BBBD procedure related adverse events will be evaluated.

    Measured: At the time of the ExAblate MRgFUS procedure

Secondary outcomes (1)

  1. Feasibility of BBB disruption

    The extent and reversibility of BBB opening will be determined by the degree of contrast enhancement seen on post-procedure MRI with contrast agent

    Measured: At the time of the ExAblate MRgFUS procedure and 24 hours post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2017
  2. Study startOct 2023 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Why it stopped: Study temporarily suspended until priorities are reassessed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03322813
Sponsor's protocol ID
BT004
Status last verified
Aug 2022
First submitted
19 Oct 2017
Last updated
3 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Anastasiadis P, Gandhi D, Guo Y, Ahmed AK, Bentzen SM, Arvanitis C, Woodworth GF. Localized blood-brain barrier opening in infiltrating gliomas with MRI-guided acoustic emissions-controlled focused ultrasound. Proc Natl Acad Sci U S A. 2021 Sep 14;118(37):e2103280118. doi: 10.1073/pnas.2103280118.

    PubMed 34504017

Questions about this trial

What is this clinical trial studying?

A study testing ExAblate 4000 - Type 2 in people with Glioma, run by InSightec at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device and procedure related adverse events (time frame: At the time of the ExAblate MRgFUS procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03322813, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.

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