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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Neurological Associates of West Los Angeles
Study ID
NCT04063514
Status
Enrolling By Invitation

Conditions

  • Low Grade Glioma of Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Focused Ultrasound — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 11, 2021
Status verified
Mar 2023
Primary completion
Apr 18, 2026
Completion
Jan 20, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Adverse Event (AE) & Serious Adverse Event (SAE) Reporting [ Time Frame: 24 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Neurological Associates of West LASanta MonicaCalifornia90403-

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By research site
Neurological Associates of West LA· Santa Monica, CA

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