Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533631
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Measuring Brain Health Using Low-Field Portable MRI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Measuring Brain Health Using Low-Field Portable MRI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MR SCREEN
Brief Summary:
The purpose of this study is to develop a new grading scale and utilize automated segmentation for measurement of White Matter Hyperintensity WMH volume using a low field MRI
Detailed Description:
This study will take place in one visit if feasible This visit will take approximately 2 hours Alternatively the visit can be split over two visits if the subject cannot tolerate two consecutive scans The pMRI and 3T MRI can occur up to one month apart
The purpose of this study is to create both a qualitative lowfield WMH scale that can be used widely and a machine learning enabled quantitative measurement of WMH for more sophisticated applications To ensure the reliability of these WMH measurement systems participants will receive both a pMRI and high-field 3T MRI at a single study visit for the purpose of comparing WMH measurements against a gold standard 3T MRI Using the Delphi method an expert panel of pMRI researchers will develop the low-field WMH grading scale iteratively refine it and validate it within this cohort Parallel to this advanced machine learning methodologies will be utilized in this cohort allowing for precise quantification of WMH volume on pMRI
The purpose of this study is to create both a qualitative lowfield WMH scale that can be used widely and a machine learning enabled quantitative measurement of WMH for more sophisticated applications To ensure the reliability of these WMH measurement systems participants will receive both a pMRI and high-field 3T MRI at a single study visit for the purpose of comparing WMH measurements against a gold standard 3T MRI Using the Delphi method an expert panel of pMRI researchers will develop the low-field WMH grading scale iteratively refine it and validate it within this cohort Parallel to this advanced machine learning methodologies will be utilized in this cohort allowing for precise quantification of WMH volume on pMRI
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