Spiral MRI Software for Improved Brain Scans

Overseen By Suzanne Hanson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnancy, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new MRI software, called Spiral MRI Software, to determine if it can make brain scans quicker, clearer, and easier to interpret. The research aims to reduce distractions for technicians, enabling them to focus more on participants rather than the scanner. Participants will undergo one 60-minute brain MRI session. The trial seeks healthy adults who are already scheduled for a standard brain MRI or those willing to participate without needing a scan. As an unphased trial, this study offers participants the chance to contribute to advancements in MRI technology that could enhance future brain scan experiences.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you take mild, oral anxiety medication for the MRI, you can continue as long as you have your own prescription and follow the consent process before taking it.

What prior data suggests that this MRI software is safe for brain scans?

Research shows that the safety of the Spiral MRI Software remains under investigation. This software aims to make MRI scans faster and clearer. As it is in an early testing phase, specific safety information from human trials is limited. However, MRI software typically does not interact directly with the body, suggesting a lower risk of side effects compared to treatments that do.

When used properly, MRI machines and their software are generally safe. No studies have identified major safety issues with the Spiral MRI Software. The software is designed to enhance imaging, so its safety concerns focus on ensuring accurate results rather than causing physical side effects. Prospective participants should consult medical professionals for personalized advice before joining any trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Spiral MRI Software because it aims to significantly enhance brain scans, offering improvements over standard MRI technology. Unlike current MRIs, which can be limited by scan time and image clarity, this software focuses on boosting scan efficiency and image quality. It also explores innovative features like gradient derating and signal-to-noise ratio (SNR) adjustments, which could provide clearer, faster, and more detailed brain images. These advancements have the potential to improve diagnostic accuracy and patient outcomes significantly.

What evidence suggests that this Spiral MRI Software is effective for improving brain scans?

Research has shown that the Spiral MRI software, tested in this trial, can make brain scans quicker and clearer. One study found it reduced scan times by more than half compared to traditional methods while maintaining image detail. The software also reduced unwanted blurry spots that can make scans difficult to interpret. Another study found that the Spiral MRI software improved image quality and enhanced the visibility of small details. Overall, this software appears promising in making MRI scans more efficient and easier to understand. Participants in this trial will be part of different arms, including those undergoing standard care MRI and various experimental arms testing the Spiral MRI software's capabilities. ^{1 3 6 7 8}

Who Is on the Research Team?

James Pipe, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for individuals who are eligible to undergo brain MRI scans. Specific eligibility criteria have not been provided, so it's likely open to a broad range of participants without major health restrictions.

Inclusion Criteria

I am over 18 and can sign a consent form myself.

I am over 18, can consent for myself, and have a brain MRI planned.

Exclusion Criteria

Contraindication(s) to or inability to undergo MRI

Currently pregnant

Unable or unwilling to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging Session

Participants complete one brain MRI imaging session using both standard and spiral MRI techniques

60 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions or feedback on the MRI experience

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Spiral MRI Software

Trial Overview The study is testing new MRI computer software designed to speed up the scanning process, reduce image artifacts, simplify interpretation, and allow technicians to focus more on patients rather than equipment during a 60-minute brain imaging session.

How Is the Trial Designed?

Group I: Healthy Participants - image quality Experimental Treatment 1 Intervention

Participants not otherwise undergoing a brain MRI

Group II: Healthy Participants - Tau Experimental Treatment 1 Intervention

Participants not otherwise undergoing a brain MRI

Group III: Healthy Participants - Scan Efficiency Experimental Treatment 1 Intervention

Participants not otherwise undergoing a brain MRI

Group IV: Healthy Participants - SNR Experimental Treatment 1 Intervention

Participants not otherwise undergoing a brain MRI

Group V: Healthy Participants - Gradient Derating Experimental Treatment 1 Intervention

Participants not otherwise undergoing a brain MRI

Group VI: Standard of Care (SOC) Brain MRI Active Control 1 Intervention

Participants undergoing SOC MRI

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07167953

Study Details | NCT07167953 | The Spiral MRI Study Participants will complete one brain MRI imaging session, lasting about 60 minutes. The overall goal of this application is to design ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8583255/

Spiral 2D T2-Weighted TSE Brain MR Imaging - PubMed Central Spiral achieved a scan time reduction of 51.9% and 21.9% compared with Cartesian and MultiVane, respectively. The number and location of lesions were identical ...

3. nature.com nature.com/articles/s41592-023-02068-7

Next-generation MRI scanner designed for ultra-high ... The resolution gains in MRI on the NexGen 7 T scanner using EPI with whole-brain coverage are volumetrically up to roughly 20 times higher ...

4. ajnr.org ajnr.org/content/41/2/238

Spiral T1 Spin-Echo for Routine Postcontrast Brain MRI ... Spiral was superior to Cartesian in 7 of 10 assessed metrics—with strong consensus benefits to flow artifact mitigation, subjective SNR, and GM/ ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1053811921010107

Advances in spiral fMRI: A high-resolution study with ... We demonstrate that high-resolution spiral fMRI at 7 T is not only feasible, but delivers both excellent image quality, BOLD sensitivity, and spatial ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150038B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) When using the ExAblate Neuro, the patient lies on a patient table that fits into a standard. MRI scanner as shown in Figure 1 above. The patient ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8597947/

A portable scanner for brain MRI - PMC - PubMed Central - NIH The complex and potentially dangerous hardware requires highly trained staff to run and maintain the equipment and a safety exclusion zone to prevent projectile ...

8. mriquestions.com mriquestions.com/best-fmri-software.html

What is the best software for processing fMRI data? Brain Voyager is a comprehensive suite of commercial programs for functional imaging analysis and visualization, including not only fMRI, but also DTI, EEG, and ...