The Use of Focused Ultrasound and DCE K-trans Imaging to Evaluate Permeability of the Blood-Brain Barrier

March 22, 2023 updated by: Neurological Associates of West Los Angeles

The limitation of treating intrinsic brain pathologies has been circumvented with neurosurgical techniques; however, less invasive approaches may be desirable particularly for widespread or multifocal disease and when long term and repetitive administration is required. This study seeks to investigate the efficacy of focused ultrasound.

Patients with either low grade gliomas or neurodegenerative dementias will be evaluated for study candidacy.

There are no immediate benefits for patients who choose to participate; however, the information gained from this study will contribute to the research base and help patients in similar situations in the future.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Treatment of intrinsic brain diseases is challenging because brain barrier (BBB) limits the delivery of drugs, particulates and cellular elements such as stem cells to the central nervous system (CNS). This limitation is often circumvented with neurosurgical techniques, however, less invasive approaches may be desirable particularly for widespread or multifocal disease and when long term and repetitive administration is required.

The diagnosis for the participants will be either low grade gliomas. A baseline fMRI and follow up routine fMRI's will be taken and evaluated for any changes in perfusion. During the scans, The ultrasound placement will last for one hour.

This study seeks to investigate the efficacy of focused ultrasound in opening the blood brain barrier. This physiological effect would have significant clinical applications. The ability to open the blood brain barrier has the potential to revolutionize the delivery of therapeutic agents to the brain, allowing for more localized and efficient delivery. There are no immediate benefits for patients who choose to participate; however, the information gained from this study will contribute to the research base and help patients in similar situations in the future.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Neurological Associates of West LA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects undergoing routine, repetitive MRI scanning for monitoring low grade gliomas
  • 18 or older

Exclusion Criteria:

• Cognitive decline with mild cognitive impairment (Clinical Dementia Rating stage 0.5) through moderate dementia CDR stages 1 and 2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Focused Ultrasound
The ultrasound treatment will last either 1 hour or 20 minutes total time for the DWL device or Brainsonix Focused Ultrasound Device, respectively.
Other: Focused Ultrasound
With focused ultrasound, there is an expected accentuation of local perfusion and potential temporary opening of the blood brain barrier with the aim is to provide better delivery of therapeutic agents including medication, particulates and cellular elements for treatment of neoplastic, inflammatory and degenerative brain diseases. The present study seeks to investigate differences in perfusion between areas treated and untreated by this modality in order to further explore its use in clinical application for the treatment of brain disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event (AE) & Serious Adverse Event (SAE) Reporting
Time Frame: 24 hours
Per protocol, any suspected adverse events possibly related to the study protocol (e.g., itching, dizziness, headache, or neurological problems) will be tracked and monitored. In the event of a high-grade or serious adverse event, such event will be reported immediately and the study will be discontinued.
24 hours
functional Magnetic Resonance Imaging (fMRI)
Time Frame: 3 hours
Some functional neuroimaging scans (e.g., high resolution T1-weighted images; Arterial Spin Labeling [ASL]; Dynamic Contrast Enhanced [DCE] perfusion sequences; post-contrast T1-weighted images, Susceptibility Weighted Imaging [SWI], T2 weighted imaging, and T2 Flair) will be used to evaluate longitudinal changes in perfusion as an efficacy measure. The scans will be acquired within one hour before and after the study procedures of focused transcranial ultrasound and infusion of definity microbubbles. Voxel-based comparisons showing perfusion values relative to the acquired data range will be used for quantification and comparison of baseline and post-procedure scans.
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurological Associates of West Los Angeles

Investigators

  • Principal Investigator: Sheldon Jordan, M.D., Neurologist, NAOWLA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Anticipated)

April 18, 2026

Study Completion (Anticipated)

January 20, 2027

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ICSS-2018-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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