The Spiral MRI Study

NCT ID: NCT07167953

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2028-08-31

Study Completion Date

2031-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain MRI

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy Participants - Scan Efficiency

Participants not otherwise undergoing a brain MRI

Group Type EXPERIMENTAL

Brain MRI - SOC and spiral

Intervention Type DEVICE

6 participants will be scanned using 2 versions (SOC and spiral) pf 6 sequences (12 scans total).

Standard of Care (SOC) Brain MRI

Participants undergoing SOC MRI

Group Type ACTIVE_COMPARATOR

Brain MRI

Intervention Type DEVICE

90 participants will undergo a 60 minute SOC brain MRI followed by 15 minute spiral MRI

Healthy Participants - Tau

Participants not otherwise undergoing a brain MRI

Group Type EXPERIMENTAL

Brain MRI - spiral

Intervention Type DEVICE

10 participants will be scanned with 3 sequences, 3 times (9 total scans per participants)

Healthy Participants - image quality

Participants not otherwise undergoing a brain MRI

Group Type EXPERIMENTAL

Brain MRI - SOC and spiral

Intervention Type DEVICE

10 participants will be scanned using 2 versions (SOC and spiral) of 6 sequences (12 scans total).

Healthy Participants - SNR

Participants not otherwise undergoing a brain MRI

Group Type EXPERIMENTAL

Brain MRI - spiral

Intervention Type DEVICE

10 participants will be scanned with 3 spiral sequences to achieve desired signal to noise ratio (SNR).

Healthy Participants - Gradient Derating

Participants not otherwise undergoing a brain MRI

Group Type EXPERIMENTAL

Brain MRI - spiral

Intervention Type DEVICE

5 participants will be scanned with 2 pairs of 6 spiral sequences.

Interventions

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Brain MRI

90 participants will undergo a 60 minute SOC brain MRI followed by 15 minute spiral MRI

Intervention Type DEVICE

Brain MRI - SOC and spiral

6 participants will be scanned using 2 versions (SOC and spiral) pf 6 sequences (12 scans total).

Intervention Type DEVICE

Brain MRI - spiral

10 participants will be scanned with 3 sequences, 3 times (9 total scans per participants)

Intervention Type DEVICE

Brain MRI - SOC and spiral

10 participants will be scanned using 2 versions (SOC and spiral) of 6 sequences (12 scans total).

Intervention Type DEVICE

Brain MRI - spiral

10 participants will be scanned with 3 spiral sequences to achieve desired signal to noise ratio (SNR).

Intervention Type DEVICE

Brain MRI - spiral

5 participants will be scanned with 2 pairs of 6 spiral sequences.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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


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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Pipe, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

Central Contacts

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Study Coordinator

Role: CONTACT

608-282-8349

Suzanne Hanson

Role: CONTACT

Facility Contacts

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Study Coordinator

Role: primary

608-282-8349

Other Identifiers

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1R01EB036009-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A539300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/RADIOLOGY/RADIOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 6/2/2025

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0948

Identifier Type: -

Identifier Source: org_study_id

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