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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01EB036009-01A1 | U.S. NIH Grant/Contract | View source | |
| A539300 | Other Identifier | UW Madison | |
| SMPH/RADIOLOGY/RADIOLOGY | Other Identifier | UW Madison | |
| Protocol Version 6/2/2025 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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The goal of this clinical trial is to find out if new Magnetic Resonance Imaging (MRI) computer software will:
Participants will complete one brain MRI imaging session, lasting about 60 minutes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Participants - Scan Efficiency | Experimental | Participants not otherwise undergoing a brain MRI |
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| Standard of Care (SOC) Brain MRI | Active Comparator | Participants undergoing SOC MRI |
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| Healthy Participants - Tau | Experimental | Participants not otherwise undergoing a brain MRI |
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| Healthy Participants - image quality | Experimental | Participants not otherwise undergoing a brain MRI |
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| Healthy Participants - SNR | Experimental | Participants not otherwise undergoing a brain MRI |
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| Healthy Participants - Gradient Derating | Experimental | Participants not otherwise undergoing a brain MRI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain MRI | Device | 90 participants will undergo a 60 minute SOC brain MRI followed by 15 minute spiral MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Healthy Controls Inclusion Criteria:
Brain MR Inclusion Criteria:
Exclusion Criteria (ALL):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 608-282-8349 | Radstudy@uwhealth.org | |
| Suzanne Hanson | Contact | shanson@uwhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| James Pipe, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison | Madison | Wisconsin | 53705 | United States |
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| Brain MRI - SOC and spiral | Device | 6 participants will be scanned using 2 versions (SOC and spiral) pf 6 sequences (12 scans total). |
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| Brain MRI - spiral | Device | 10 participants will be scanned with 3 sequences, 3 times (9 total scans per participants) |
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| Brain MRI - SOC and spiral | Device | 10 participants will be scanned using 2 versions (SOC and spiral) of 6 sequences (12 scans total). |
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| Brain MRI - spiral | Device | 10 participants will be scanned with 3 spiral sequences to achieve desired signal to noise ratio (SNR). |
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| Brain MRI - spiral | Device | 5 participants will be scanned with 2 pairs of 6 spiral sequences. |
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| 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 |