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The Use of Focused Ultrasound and Microbubble Infusion for Altering Brain Perfusion and the Blood Brain Barrier

Study Purpose

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 combined with microbubbles in opening the blood brain barrier. Patients with either low grade gliomas or neurodegenerative dementias will be evaluated for study candidacy. Participants will receive an intravenous infusion of Definity micro bubbles in tandem with focused ultrasound; a pre-and-post fMRI will be obtained to evaluate any changes in perfusion. 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04063514
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Neurological Associates of West Los Angeles
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sheldon Jordan, M.D.
Principal Investigator Affiliation Neurologist, NAOWLA
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Low Grade Glioma of Brain
Additional Details

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, during which, there will be an infusion of Definity microbubbles intravenously over ten to thirty minutes as per routine approved application. This study seeks to investigate the efficacy of focused ultrasound combined with microbubbles 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.

Arms & Interventions

Arms

Experimental: Focused Ultrasound and Microbubble Infusion

The ultrasound treatment will last either 1 hour or 20 minutes total time for the DWL device. An infusion of Definity microbubbles will be infused intravenously over ten to thirty minutes as per routine approved application. Definity will be 1.3 mL added to 50 mL saline and infused no faster than 4 mL/minute.

Interventions

Other: - Focused Ultrasound and Microbubble Infusion

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Neurological Associates of West LA, Santa Monica, California

Status

Address

Neurological Associates of West LA

Santa Monica, California, 90403