Quantitative Imaging of Brain Glymphatic Function in Humans
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|ClinicalTrials.gov Identifier: NCT04768101|
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : April 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: C-11 PiB||Early Phase 1|
The proposal involves magnetic resonance imaging (MRI) of healthy volunteers and patient volunteers suffering from Parkinson's disease. As part of the research study, volunteers will undergo 1-2 non-invasive MRI scans at a field strength of 3 Tesla. Each scan session will last 60-90 minutes, and will include the time when the volunteers will rehearse the experiment outside of the scanner, time for the volunteers and patients to be comfortably placed in the scanner, scanning, and finally time for the patients to slowly exit the scan room.
All MRI methods are non-invasive and no exogenous contrast agents will be required.
Patient volunteers will also undergo an C-11 PiB PET scan for Aim (2). This procedure utilizes a common radiotracer that is used routinely in clinical PET scans and will be purchased here from PETNET and certified for human use. All PET scans will be performed by a certified PET technologist at the Vanderbilt University Institute of Imaging Science.
Finally, in Aim (3) of this study, measurements of glymphatic function will be performed before and during general anesthesia. Importantly, the general anesthesia will be administered as part of standard-of-care for clinically-indicated MRIs required for deep brain stimulation planning and electrode placement. Therefore, the intervention itself is not a research procedure. Additionally, the scan that will be performed, which is a modified diffusion tensor imaging (DTI) MRI approach, is already performed as part of this clinical protocol. Therefore, it is anticipated that the participant will not be sedated any longer than what would be required for clinical indication for this procedure. As such, while this study qualifies as a clinical trial by NIH criteria, it is expected to pose no more risk than what the participant will receive from their clinical standard-of-care procedure.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||There is no masking in this protocol.|
|Masking:||None (Open Label)|
|Masking Description:||There is no masking in this protocol.|
|Primary Purpose:||Basic Science|
|Official Title:||Quantitative Imaging of Brain Glymphatic Function in Humans|
|Actual Study Start Date :||April 15, 2020|
|Estimated Primary Completion Date :||February 28, 2024|
|Estimated Study Completion Date :||February 28, 2025|
Experimental: Parkinson's Disease participants with MCI
Patient volunteers will also undergo a C-11 PiB PET scan. This procedure utilizes a common radiotracer that is used routinely in clinical PET scans and will be purchased here from PETNET and certified for human use. All PET scans will be performed by a certified PET technologist at the Vanderbilt University Institute of Imaging Science.
Drug: C-11 PiB
C-11 PiB is a PET radiotracer used to evaluate levels of Αβ burden.
- Diffusion Tensor Imaging Along Perivascular Spaces (DTI-ALPS) [ Time Frame: baseline, under anesthesia ]Using a 3T MRI (body coil transmission and SENSE phased-array 32-channel reception), images will be taken. For analysis, a unitless ratio of diffusion along perivascular space relative to orthogonal to perivascular space at the level of the lateral brain ventricles will be calculated
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04768101
|Contact: Kaitlyn R Hay, M.S.||firstname.lastname@example.org|
|Contact: James Silverman, Ph.D.||email@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37212|
|Contact: Kaitlyn Hay, MS 615-875-7403 firstname.lastname@example.org|
|Contact: James Silverman, PhD 615-875-5778 email@example.com|
|Principal Investigator: Manus J Donahue, Ph.D.|
|Sub-Investigator: Daniel O Claassen, M.D.|
|Principal Investigator:||Manus J Donahue, Ph.D.||Vanderbilt University Medical Center|