The Use of Focused Ultrasound and DCE K-trans Imaging to Evaluate Permeability of the Blood-Brain Barrier
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Grade Glioma of Brain
- Sponsor
- Neurological Associates of West Los Angeles
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Adverse Event (AE) & Serious Adverse Event (SAE) Reporting
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
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.