Ignite Creation Date:
2024-05-06 @ 7:58 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02638519
Status:
TERMINATED
Last Update Posted:
2023-05-01
First Post:
2015-12-03
Brief Title:
HP Xenon-129 fMRI of Healthy Volunteers and Participants With Alzheimers Disease
Sponsor:
Thunder Bay Regional Health Research Institute
Organization:
Thunder Bay Regional Health Research Institute
Study Overview
Official Title:
Hyperpolarized Xenon-129 Functional Magnetic Resonance Imaging of Healthy Volunteers and Participants With Alzheimers Disease
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to reach the target enrollment of 40 participants with Alzheimers disease
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study involves imaging participants brains using MRI The goal is to develop a high-resolution high-sensitivity imaging tool hyperpolarized xenon functional brain magnetic resonance imaging which can provide more sensitive measurement of brain function facilitating the development of drugs for more successful treatment of Alzheimers disease
Detailed Description:
The described study is a pilot study in which the investigators aim to develop an enhanced sensitivity tool for assessment of neural function Participation involves at least two study visits no longer than three hours in length each During visit 1 informed consent and screening for eligibility will take place During visit 2 fMRI scanning will take place in which participants will complete simple tasks Two types of MRI scans will be performed traditional proton fMRI and hyperpolarized xenon-129 fMRI HP 129Xe fMRI scans The trade name for xenon-129 hyperpolarized with a Xemed LLC polarizer is NeuroXene
Participants will be placed in the 3T MRI at the Thunder Bay Regional Research Institute with a Clinical MR Solutions CMRS Dual Brain Coil that fits over their head like a helmet Several inhalation procedures will be performed by participants when breathing NeuroXene from a tube in the scanner Preparation and administration of NeuroXene and the CMRS Dual Brain Coil will be carried out according to the SOPs developed by the TBRRI and Xemed LLC
MRI scanning will be performed with a MR Tech and Registered Respiratory Therapist present Dispensing of 129Xe will be monitored using a gas dispensing form and a drug accountability log This study will have a monitor assigned to it from the TBRRI that is not involved in this clinical trial This is to ensure participant safety and adherence to the protocol
Participants will be placed in the 3T MRI at the Thunder Bay Regional Research Institute with a Clinical MR Solutions CMRS Dual Brain Coil that fits over their head like a helmet Several inhalation procedures will be performed by participants when breathing NeuroXene from a tube in the scanner Preparation and administration of NeuroXene and the CMRS Dual Brain Coil will be carried out according to the SOPs developed by the TBRRI and Xemed LLC
MRI scanning will be performed with a MR Tech and Registered Respiratory Therapist present Dispensing of 129Xe will be monitored using a gas dispensing form and a drug accountability log This study will have a monitor assigned to it from the TBRRI that is not involved in this clinical trial This is to ensure participant safety and adherence to the protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None