Low Grade Glioma of Brain Clinical Trial
Official title:
The Use of Focused Ultrasound and DCE K-trans Imaging to Evaluate Permeability of the Blood-Brain Barrier
Verified date | March 2023 |
Source | Neurological Associates of West Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 15 |
Est. completion date | January 20, 2027 |
Est. primary completion date | April 18, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Neurological Associates of West LA | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Neurological Associates of West Los Angeles |
United States,
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Hynynen K, McDannold N, Vykhodtseva N, Jolesz FA. Noninvasive MR imaging-guided focal opening of the blood-brain barrier in rabbits. Radiology. 2001 Sep;220(3):640-6. doi: 10.1148/radiol.2202001804. — View Citation
Hynynen K, McDannold N, Vykhodtseva N, Raymond S, Weissleder R, Jolesz FA, Sheikov N. Focal disruption of the blood-brain barrier due to 260-kHz ultrasound bursts: a method for molecular imaging and targeted drug delivery. J Neurosurg. 2006 Sep;105(3):445-54. doi: 10.3171/jns.2006.105.3.445. — View Citation
McDannold N, Vykhodtseva N, Hynynen K. Targeted disruption of the blood-brain barrier with focused ultrasound: association with cavitation activity. Phys Med Biol. 2006 Feb 21;51(4):793-807. doi: 10.1088/0031-9155/51/4/003. Epub 2006 Jan 25. — View Citation
McDannold N, Vykhodtseva N, Hynynen K. Use of ultrasound pulses combined with Definity for targeted blood-brain barrier disruption: a feasibility study. Ultrasound Med Biol. 2007 Apr;33(4):584-90. doi: 10.1016/j.ultrasmedbio.2006.10.004. — View Citation
McDannold N, Vykhodtseva N, Raymond S, Jolesz FA, Hynynen K. MRI-guided targeted blood-brain barrier disruption with focused ultrasound: histological findings in rabbits. Ultrasound Med Biol. 2005 Nov;31(11):1527-37. doi: 10.1016/j.ultrasmedbio.2005.07.01 — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Event (AE) & Serious Adverse Event (SAE) Reporting | 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. | 24 hours | |
Primary | functional Magnetic Resonance Imaging (fMRI) | 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. | 3 hours |
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