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

Neurological Associates of West Los Angeles

Status: Invitation-only

Conditions: Low Grade Glioma of Brain

Treatments: Other: Focused Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04063514

ICSS-2018-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Focused Ultrasound

Experimental group

Description:

The ultrasound treatment will last either 1 hour or 20 minutes total time for the DWL device or Brainsonix Focused Ultrasound Device, respectively.

Treatment:

Other: Focused Ultrasound