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NCT Number: NCT07167953

The Spiral MRI Study

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location contact

James Pipe, PhD

PRINCIPAL_INVESTIGATOR

Study Coordinator

CONTACT

[email protected]

608-282-8349

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain MRI

Device

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

Brain MRI - SOC and spiral

Device

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

Brain MRI - spiral

Device

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

Primary outcomes

  1. Image quality - decreasing scan time

    Time frame: 60 minutes

    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.

  2. Image quality - tau

    Time frame: 60 minutes

    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).

  3. Image quality - consistent scan time

    Time frame: 60 minutes

    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.

  4. Signal to Noise Ratio (SNR)

    Time frame: 60 minutes

    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.

  5. Image quality - acoustic comfort

    Time frame: 60 minutes

    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).

  6. Acoustic noise

    Time frame: 60 minutes

    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.

  7. Difference in Image quality

    Time frame: 60 minutes

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

608-282-8349

Suzanne Hanson

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

MRI Technology for Greater Efficiency and Improved Value

Important dates

Study start
2028
Primary completion
2031
Study completion
2031
First posted
Sep 11, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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