NCT07167953

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Aug 2028

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
2.9 years until next milestone

Study Start

First participant enrolled

August 1, 2028

Expected
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2031

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

September 3, 2025

Last Update Submit

September 16, 2025

Conditions

Brain MRI

Outcome Measures

Primary Outcomes (7)

  • Image quality - decreasing scan time

    Participants will be scanned using 2 versions (standard and spiral) of 6 sequences (12 scans total). For each sequence pair, scan time will be sped up. Image quality will be compared between the 2 versions.

    60 minutes

  • Image quality - tau

    Measuring whether image quality is sufficient for routine diagnostic interpretation - specifically robustness to artifacts. The independent variable is a scanning parameter called tau, which researchers want to be long (because it makes the total scan time shorter). Researchers will compare the value of tau between SOC imaging and spiral. They will use a 5-point Likert scale to compare, where 1= undiagnostic (unacceptable), 2 = spiral scans slightly worse than SOC but acceptable, 3= spiral scans same as SOC (acceptable), 4= spiral scans slightly better than SOC (acceptable), 5=spiral scans much better than SOC (acceptable).

    60 minutes

  • Image quality - consistent scan time

    Participants will be scanned using 2 versions (standard and designed) of 6 sequences (12 scans total). Scan time will remain the same for each pair. Radiologists will compare each pair for differences in image quality using a 5-point Likert scale where 1= A much worse than B, 2=A slightly worse than B, 3=A comparable to B, 4=A slightly better than B, 5=A much better than B. A=new spiral scans and B=SOC scans.

    60 minutes

  • Signal to Noise Ratio (SNR)

    Measuring the SNR in images, by measuring the signal strength in the image and the calculated noise in those images and taking the ratio. Researchers will compare this SNR to that which their methods predicted.

    60 minutes

  • Image quality - acoustic comfort

    Image quality will be compared between running at full strength, which is noisy, and running at reduced strength, which should be quieter. A 5-point Likert scale will be used, where 1= A much worse than B, 2=A slightly worse than B, 3=A comparable to B, 4=A slightly better than B, 5=A much better than B. A=spiral scans with full gradient strength and B=spiral scans with reduced gradient strength (that should be quieter).

    60 minutes

  • Acoustic noise

    Scans will be compared between running at full strength and running at reduced strength. Participants will rate the acoustic noise using a 5-point Likert scale, where 1= A much louder than B, 2=A slightly louder than B, 3=A comparable to B, 4=A slightly quieter than B, 5=A much quieter than B. A=spiral scans with full gradient strength and B=spiral scans with reduced gradient strength.

    60 minutes

  • Difference in Image quality

    Based on the results of the other 5 outcome measures, specifically whether scan time impacts image quality, the desired time will be used and scans will be compared between SOC and their method. Image quality will be measured using a 5-point Likert scale, where 1= A much worse than B, 2=A slightly worse than B, 3=A comparable to B, 4=A slightly better than B, 5=A much better than B. A=new spiral scans and B=SOC scans.

    60 minutes

Study Arms (6)

Healthy Participants - Scan Efficiency

EXPERIMENTAL

Participants not otherwise undergoing a brain MRI

Device: Brain MRI - SOC and spiral

Standard of Care (SOC) Brain MRI

ACTIVE COMPARATOR

Participants undergoing SOC MRI

Device: Brain MRI

Healthy Participants - Tau

EXPERIMENTAL

Participants not otherwise undergoing a brain MRI

Device: Brain MRI - spiral

Healthy Participants - image quality

EXPERIMENTAL

Participants not otherwise undergoing a brain MRI

Device: Brain MRI - SOC and spiral

Healthy Participants - SNR

EXPERIMENTAL

Participants not otherwise undergoing a brain MRI

Device: Brain MRI - spiral

Healthy Participants - Gradient Derating

EXPERIMENTAL

Participants not otherwise undergoing a brain MRI

Device: Brain MRI - spiral

Interventions

Brain MRIDEVICE

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

Standard of Care (SOC) Brain MRI
Brain MRI - SOC and spiralDEVICE

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

Healthy Participants - Scan Efficiency
Brain MRI - spiralDEVICE

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

Healthy Participants - Tau

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

Study Officials

  • James Pipe, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

608-282-8349Radstudy@uwhealth.org

Suzanne Hanson

CONTACT

shanson@uwhealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 11, 2025

Study Start (Estimated)

August 1, 2028

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

May 1, 2031

Last Updated

September 17, 2025

Record last verified: 2025-09

Locations

US(1)