Clinical trial NCT04063514: The Use of Focused Ultrasound and DCE K-trans Imaging to Evaluate Permeability of the Blood-Brain Barrier
Official title: The Use of Focused Ultrasound and DCE K-trans Imaging to Evaluate Permeability of the Blood-Brain Barrier
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Low Grade Glioma of Brain
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Event (AE) & Serious Adverse Event (SAE) Reporting
timeFrame: 24 hours
measure: functional Magnetic Resonance Imaging (fMRI)
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West LA
state: California
Study officials:
affiliation: Neurologist, NAOWLA
name: Sheldon Jordan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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