Investigational MRI Techniques for Imaging Assessment

Overseen By Michael V Knopp, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Pacemaker, Claustrophobia, Pregnancy, 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 aims to improve MRI (Magnetic Resonance Imaging) techniques, focusing on their potential use in future clinical tests. Researchers are testing two different MRI methods: one in addition to usual care and one as a standalone method. They aim to gather data on which method works best. This trial might suit someone already receiving a standard MRI at The Ohio State University or a healthy volunteer willing to try a new kind of MRI.

As an unphased trial, this study offers participants the opportunity to contribute to advancements in MRI technology that could enhance future medical diagnostics.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these MRI techniques are safe?

Research has shown that MRI (magnetic resonance imaging) is generally safe for most people. It uses strong magnets and radio waves to capture images of the body's interior. Studies indicate little long-term risk from MRI exposure. Although some individuals might experience minor, temporary effects, these are rare.

Following safety procedures is crucial, as mistakes can lead to injuries, though these are uncommon. Trained technologists ensure everything proceeds smoothly.

Overall, MRIs are well-tolerated and typically do not cause problems. They are widely used in hospitals and clinics worldwide. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative MRI techniques that could improve how we assess medical conditions. Unlike standard MRI scans, which are typically used alone, these investigational MRI methods are being tested both alongside and separate from standard care to see if they provide additional insights. The goal is to determine whether these enhanced imaging techniques can offer more detailed information, potentially leading to earlier and more accurate diagnoses. This could revolutionize how we use MRI technology in healthcare, making it a more powerful tool for doctors and patients alike.

What evidence suggests that these MRI techniques are effective for imaging assessment?

Research has shown that MRI scans effectively provide clear images of the body's interior. One study found that whole-body MRI detected additional disease sites that other scans, such as CT, might miss in over 53% of patients. Known for their accuracy, MRI scans often match or surpass other methods in diagnosing conditions like brain disorders. Additionally, MRI can help avoid unnecessary treatments and speed up diagnosis, enhancing patient care. The overall effectiveness of MRI is evident, making it a valuable tool for medical evaluation.

In this trial, participants will undergo investigational MRI techniques. Some will receive MRI scans in addition to standard care, while others will not have MRI scans as part of their standard care. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael V Knopp, MD, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for adults who can safely undergo an MRI, including those already scheduled for a standard MRI at The Ohio State University. It's not suitable for individuals with metal implants, pacemakers, certain tattoos, or conditions that affect MRI safety; nor pregnant women, prisoners, or those unable to consent.

Inclusion Criteria

Patients receiving a standard of care 1.5 or 3T MRI at The Ohio State University

Healthy volunteers that feel comfortable receiving an investigational MRI

Exclusion Criteria

I am unable to understand or sign the consent form.

Participants with a contraindication to MRI. Such contraindications include, but are not limited to: pacemaker, metallic cardiac valve(s), magnetic material such as surgical clips, tattoos, implanted electronic infusion pumps or any other condition that would interfere with the MRI, a stent somewhere, a history of allergic reaction to any metals

Participants who are pregnant, healthy volunteers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo investigational MRI sequences in addition to standard of care imaging

Up to 2 hours per session

1 visit (in-person)

Data Analysis

Post-processing techniques are applied to MRI data for analysis

Ongoing throughout study

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

1-3 years

What Are the Treatments Tested in This Trial?

Interventions

• MRI Scan - in addition to standard of care
• MRI Scan - not in addition to standard of care

Trial Overview The study is testing new ways of doing and processing MRI scans to improve the technique. Some participants will receive these investigational MRIs in addition to their standard care while others will get them separately.

How Is the Trial Designed?

Group I: Patient population Experimental Treatment 1 Intervention

Group II: Healthy volunteer population Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7036752/

Value of MRI in Medicine: More Than Just Another Test? - PMC Magnetic resonance imaging (MRI) is a pivotal, diverse modality, used to evaluate a range of morphological and functional targets. It is a highly versatile ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/jmri.26647

Measuring the value of MRI: Comparative effectiveness & ... Outcomes of MRI can include survival but also intermediate steps such as potential reduction in unnecessary therapy, shorter time to the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1078817425002433

Exploring the accuracy of whole-body MRI in assessing ... Kosmin et al., showed that whole-body MRI reported additional sites of disease that were not reported by CT in 53.3 % of patients. Analysis was ...

4. ijhpr.biomedcentral.com ijhpr.biomedcentral.com/articles/10.1186/s13584-024-00593-0

Exploring pre-MRI imaging tests: patient survey reveals ... Results showed that 60% of participants underwent other imaging tests before their MRI scan. Of those, computed tomography (CT) scans (43%), X- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10827017/

Effectiveness of radiology modalities in diagnosing and ... Conclusion: Our study revealed that CT and MRI were accurate by more than 75% and no difference was between both techniques to detect neurological disorders.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK604477/

MRI Patient Safety And Care - StatPearls - NCBI Bookshelf Current research indicates minimal long-term harm from extended magnetic resonance imaging (MRI) exposure, yet minor reversible effects from ...

7. radiology.ucsf.edu radiology.ucsf.edu/patient-care/patient-safety/mri/potential-hazards-risks

Potential Hazards and Risks | UCSF Radiology Magnetic Field Risk The static magnetic field of the MRI system is exceptionally strong. · Radio-frequency (RF) Field Risk The radio-frequency field may induce ...

8. asrt.org asrt.org/docs/default-source/research/whitepapers/asrt18_mrsafetywhitepaper.pdf?sfvrsn=ca0222d0_12

Radiologic Technologist Best Practices for MR Safety MR technologists are responsible for document- ing all diagnostic, treatment, and patient data in the medical record in a timely manner.15 MR technologists who ...

9. en.wikipedia.org en.wikipedia.org/wiki/Safety_of_magnetic_resonance_imaging

Safety of magnetic resonance imaging Magnetic resonance imaging (MRI) is in general a safe technique, although injuries may occur as a result of failed safety procedures or human error.

10. mri.medicine.uiowa.edu mri.medicine.uiowa.edu/mri-safety

MRI Safety | Magnetic Resonance Research Facility The MRI magnet is ALWAYS on. This means no person is allowed to enter the MRI scan room without clearance and permission from a certified technologist.