Brain MRINCT07167953
The Spiral MRI Study
A study testing Brain MRI, Brain MRI - SOC and spiral and Brain MRI - spiral in people with Brain MRI, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain MRI
- What is being tested?
- Brain MRI, Brain MRI - SOC and spiral and Brain MRI - spiral
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2028to May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Suzanne Hanson contact
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Study Coordinator, 608-282-8349, Radstudy@uwhealth.org
James Pipe, PhD
About this study
Official title: MRI Technology for Greater Efficiency and Improved Value
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.
Read the detailed 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.
- Conditions
- Brain MRI
- Being tested
- Brain MRI, Brain MRI - SOC and spiral, Brain MRI - spiral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIDevice
90 participants will undergo a 60 minute SOC brain MRI followed by 15 minute spiral MRI
Brain MRI - SOC and spiralDevice
6 participants will be scanned using 2 versions (SOC and spiral) pf 6 sequences (12 scans total).
Brain MRI - spiralDevice
10 participants will be scanned with 3 sequences, 3 times (9 total scans per participants)
Brain MRI - SOC and spiralDevice
10 participants will be scanned using 2 versions (SOC and spiral) of 6 sequences (12 scans total).
Brain MRI - spiralDevice
10 participants will be scanned with 3 spiral sequences to achieve desired signal to noise ratio (SNR).
Brain MRI - spiralDevice
5 participants will be scanned with 2 pairs of 6 spiral sequences.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants - Scan Efficiency | Experimental | Participants not otherwise undergoing a brain MRI Receives: Device: Brain MRI - SOC and spiral |
| Standard of Care (SOC) Brain MRI | Active comparator | Participants undergoing SOC MRI Receives: Device: Brain MRI |
| Healthy Participants - Tau | Experimental | Participants not otherwise undergoing a brain MRI Receives: Device: Brain MRI - spiral |
| Healthy Participants - image quality | Experimental | Participants not otherwise undergoing a brain MRI Receives: Device: Brain MRI - SOC and spiral |
| Healthy Participants - SNR | Experimental | Participants not otherwise undergoing a brain MRI Receives: Device: Brain MRI - spiral |
| Healthy Participants - Gradient Derating | Experimental | Participants not otherwise undergoing a brain MRI Receives: Device: Brain MRI - spiral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study startAug 2028 (estimated)
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MRIStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- James Pipe, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167953
- Sponsor's protocol ID
- 2025-0948
- Other IDs
- 1R01EB036009-01A1, A539300, SMPH/RADIOLOGY/RADIOLOGY, Protocol Version 6/2/2025
- Status last verified
- Jun 2026
- First submitted
- 3 Sep 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Technology for Greater Efficiency and Improved Value
- ClinicalTrials.gov ID
- NCT07167953
- Acronym / sponsor ID
- 2025-0948
- Conditions
- Brain MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Aug 2028 (estimated)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants - Scan Efficiency | Experimental | Device: Brain MRI - SOC and spiralParticipants not otherwise undergoing a brain MRI |
| Standard of Care (SOC) Brain MRI | Active comparator | Device: Brain MRIParticipants undergoing SOC MRI |
| Healthy Participants - Tau | Experimental | Device: Brain MRI - spiralParticipants not otherwise undergoing a brain MRI |
| Healthy Participants - image quality | Experimental | Device: Brain MRI - SOC and spiralParticipants not otherwise undergoing a brain MRI |
| Healthy Participants - SNR | Experimental | Device: Brain MRI - spiralParticipants not otherwise undergoing a brain MRI |
| Healthy Participants - Gradient Derating | Experimental | Device: Brain MRI - spiralParticipants not otherwise undergoing a brain MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRI90 participants will undergo a 60 minute SOC brain MRI followed by 15 minute spiral MRI | Device | Standard of Care (SOC) Brain MRI |
| Brain MRI - SOC and spiral6 participants will be scanned using 2 versions (SOC and spiral) pf 6 sequences (12 scans total). | Device | Healthy Participants - Scan Efficiency |
| Brain MRI - spiral10 participants will be scanned with 3 sequences, 3 times (9 total scans per participants) | Device | Healthy Participants - Tau |
| Brain MRI - SOC and spiral10 participants will be scanned using 2 versions (SOC and spiral) of 6 sequences (12 scans total). | Device | Healthy Participants - image quality |
| Brain MRI - spiral10 participants will be scanned with 3 spiral sequences to achieve desired signal to noise ratio (SNR). | Device | Healthy Participants - SNR |
| Brain MRI - spiral5 participants will be scanned with 2 pairs of 6 spiral sequences. | Device | Healthy Participants - Gradient Derating |
Primary outcome
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.
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).
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.
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.
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).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne Hanson contact
James Pipe, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRI, Brain MRI - SOC and spiral and Brain MRI - spiral in people with Brain MRI, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (608-282-8349, Radstudy@uwhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality - decreasing scan time (time frame: 60 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.