The Spiral MRI Study

University of Wisconsin (UW)

Status: Begins enrollment in a year or more

Conditions: Brain MRI

Treatments: Device: Brain MRI - SOC and spiral; Device: Brain MRI - spiral; Device: Brain MRI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07167953

1R01EB036009-01A1 (U.S. NIH Grant/Contract)

2025-0948

SMPH/RADIOLOGY/RADIOLOGY (Other Identifier)

A539300 (Other Identifier)

Protocol Version 6/2/2025 (Other Identifier)

Details and patient eligibility

About

The goal of this clinical trial is to find out if new Magnetic Resonance Imaging (MRI) computer software will:

• help make scans and exams faster
• reduce artifacts
• make MRI easier to understand
• allow technicians to focus more on the participant and less on the scanner

Participants will complete one brain MRI imaging session, lasting about 60 minutes.

Full description

The overall goal of this application is to design technologies that improve the value of MRI, and specifically mitigate many of the complications that negatively impact this value. The scope of MRI value is vast, but can be expressed by efficiency (high patient throughput and consistent image quality), accessibility (better scope of use and equity of availability), safety, and user experience for the patient, technologist, and interpreting physician.

Enrollment: 131 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy Controls Inclusion Criteria:

• Adults at least 18 years
• Able to provide written informed consent on their own behalf

Brain MR Inclusion Criteria:

• Adults at least 18 years
• Able to provide written informed consent on their own behalf
• Scheduled for standard of care brain MRI

Exclusion Criteria (ALL):

• Unable or unwilling to provide informed consent
• Contraindication(s) to or inability to undergo MRI
• Currently pregnant
• Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed as long as the following criteria are met:
• participant has their own prescription for the medication
• informed consent process is conducted prior to the self-administration of the medication
• they come to the research visit with a driver

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 6 patient groups

Healthy Participants - Scan Efficiency

Experimental group

Description:

Participants not otherwise undergoing a brain MRI

Treatment:

Device: Brain MRI - SOC and spiral

Device: Brain MRI - SOC and spiral

Standard of Care (SOC) Brain MRI

Active Comparator group

Description:

Participants undergoing SOC MRI

Treatment:

Device: Brain MRI

Healthy Participants - Tau

Experimental group

Description:

Participants not otherwise undergoing a brain MRI

Treatment:

Device: Brain MRI - spiral

Device: Brain MRI - spiral

Device: Brain MRI - spiral

Healthy Participants - image quality

Experimental group

Description:

Participants not otherwise undergoing a brain MRI

Treatment:

Device: Brain MRI - SOC and spiral

Device: Brain MRI - SOC and spiral

Healthy Participants - SNR

Experimental group

Description:

Participants not otherwise undergoing a brain MRI

Treatment:

Device: Brain MRI - spiral

Device: Brain MRI - spiral

Device: Brain MRI - spiral

Healthy Participants - Gradient Derating

Experimental group

Description:

Participants not otherwise undergoing a brain MRI

Treatment:

Device: Brain MRI - spiral

Device: Brain MRI - spiral

Device: Brain MRI - spiral