Measuring Brain Health Using Low-Field Portable MRI (MR SCREEN)

Yale University

Status: Enrolling

Conditions: White Matter Hyperintensity

Treatments: Device: Portable low-field MRI (pMRI); Device: 3T MRI

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06533631

2000037836

1R21NS138995-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• One vascular risk factor, from the following:

  1. Hypertension (defined as taking an antihypertensive medication)
  2. Hyperlipidemia (defined as taking a statin or PCSK9 inhibitor)
  3. Diabetes (defined as taking a medication to prevent hyperglycemia)

Exclusion criteria

• 1. History of stroke
• History of dementia or other cognitive impairment
• Pacemaker or other MRI contraindications according to the American College of Radiology guidelines

Trial design

100 participants in 1 patient group

pMRI and 3T MRI

Description:

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).

Treatment:

Device: 3T MRI

Device: Portable low-field MRI (pMRI)