NCT04063514

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

Enrolling by Invitation
NAAges 18+InterventionalTreatment
Neurological Associates of West Los Angeles
~15 participants
Updated 2023-03-24 on ClinicalTrials.gov
What's tested:Focused Ultrasound

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Event (AE) & Serious Adverse Event (SAE) Reporting
Measured over 24 hours
+1 more outcome measured
Low Grade Glioma of Brain
1 sites across 1 states
California1
  • Sheldon Jordan, M.D. · PRINCIPAL_INVESTIGATOR · Neurologist, NAOWLA

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Eligibility criteria

Inclusion

Subjects undergoing routine, repetitive MRI scanning for monitoring low grade gliomas
18 or older
  • Adverse Event (AE) & Serious Adverse Event (SAE) Reporting24 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)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.