MRI Development Study

Overseen By Rob Fraser, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GE HealthCare Technologies Inc

Disqualifiers: Unhealthy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

10000 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test and potentially improve MRI devices. A MR device is used to take pictures of the inside of the body and those used in this study are investigational or experimental meaning they have not been approved by the FDA for use in humans. We are looking for healthy volunteers to receive MRI scans at GE Healthcare in Aurora. Participating in the study is voluntary.

Do I need to stop my current medications for the MRI study?

The protocol does not specify whether you need to stop taking your current medications for this study.

What data supports the effectiveness of the treatment MRI?

Research shows that MRI is effective in diagnosing various conditions, which can lead to quicker and more accurate treatment decisions. This can reduce unnecessary treatments and hospital stays, ultimately improving patient outcomes. ^{1 2 3 4 5}

Is MRI generally safe for humans?

MRI is generally considered safe for humans, but there can be rare adverse events, especially when using contrast agents like gadolinium. Studies have shown that while these events are uncommon, they can occur, so it's important to discuss any concerns with your doctor before the procedure. ^{6 7 8 9 10}

How is MRI different from other treatments for this condition?

MRI is unique because it uses magnetic fields and radio waves to create detailed images of the inside of the body, unlike other treatments that might involve medication or surgery. Recent advancements in MRI technology, such as high-resolution imaging and the use of contrast agents, allow for more precise and detailed visualization, which can be particularly useful in studying development and other conditions. ^{11 12 13 14 15}

Research Team

Rob Fraser, MD

Principal Investigator

GE HealthCare Technologies Inc

Eligibility Criteria

This clinical trial is open to individuals who are eligible for MRI scans. Specific eligibility criteria are not provided, but typically participants should not have any contraindications to MRI such as certain metal implants, claustrophobia without sedation options, or severe medical conditions affecting the ability to lie still.

Inclusion Criteria

Are you able to walk 350 feet and climb two steps without assistive devices?

Are you able to hear and understand English without an assistive device?

Do you have a photo ID?

Exclusion Criteria

Do you have any type of metal implant, prosthetic, implanted pacemaker or defibrillator, or previous injury involving a metallic object?

Do you have 1 or more tattoos?

Are you claustrophobic or do you have a medical condition that may prevent you from holding still?

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Scanning

Participants receive investigational MRI scans to test and potentially improve MRI devices

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after MRI scans

4 weeks

Treatment Details

Interventions

• MRI

Trial Overview The study is focused on evaluating the performance of an MRI system along with its components and accessories. Participants will undergo scan sessions aimed at collecting data that helps in assessing the development of these systems.

Participant Groups

Group I: the study Experimental Treatment 1 Intervention

Patients with a PPM or ICD getting a clinically indicated MRI

Who Is Running the Clinical Trial?

GE HealthCare Technologies Inc

Lead Sponsor

Trials

1

Recruited

10,000+

Findings from Research

In a study involving 103 medical and neurologic inpatients, 89% of physicians found that MR imaging significantly enhanced diagnostic information, aiding in diagnosis, treatment planning, and prognosis estimation.

MR imaging was particularly beneficial in cases of diagnostic uncertainty, as it more often decreased confidence in incorrect presumptive diagnoses rather than increasing it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical assessment of MR of the brain in nonsurgical inpatients. Hirsch, JA., Langlotz, CP., Lee, J., et al.[2021]

The study successfully improved patient access to MRI scans within 24 hours from 53% to over 90% by identifying and addressing 14 key failure modes in the MRI process.

Process improvements led to a reduction in mean cycle time from 52 to 39 minutes, increased monthly throughput by 38%, and enhanced scanner productivity by 32%, resulting in estimated savings of €247,000 in the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing same-day access to magnetic resonance imaging. Zhang, L., Hefke, A., Figiel, J., et al.[2019]

In a study involving 19 individuals with chronic incomplete spinal cord injury and 16 healthy controls, specific measures of spinal cord atrophy (anterior-posterior width and left-right width) were found to correlate with sensory and motor outcomes, indicating their potential as reliable indicators of functional impairment.

The research suggests that these MRI-derived measurements can independently assess sensory and motor functions, aligning with the anatomical locations of the main sensory and motor pathways in the spinal cord.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Independent spinal cord atrophy measures correlate to motor and sensory deficits in individuals with spinal cord injury. Lundell, H., Barthelemy, D., Skimminge, A., et al.[2022]

Team training for MRI staff significantly improved patient no-show rates from 11.2% to 8.7% and incompletion rates from 2.3% to 1.4%, based on an analysis of 97,712 patient visits over one year.

The training included advanced communication techniques and case simulations, demonstrating that effective team training can enhance patient engagement and optimize the use of MRI services in a cost-sensitive healthcare environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of team training on improving MRI study completion rates and no-show rates. Norbash, A., Yucel, K., Yuh, W., et al.[2018]

MRI is a valuable diagnostic tool that can improve health outcomes by providing detailed information on lesions and treatment responses, but its effectiveness must be compared to other diagnostic methods in terms of sensitivity, specificity, and overall impact on patient care.

Understanding the cost-effectiveness of MRI compared to other imaging modalities is crucial for health policy decisions, as it helps determine the best use of resources to maximize patient benefits and improve healthcare quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the value of MRI: Comparative effectiveness & outcomes research. Kang, SK.[2020]

Over a 10-year period, the FDA received 1568 reports of adverse events related to magnetic resonance (MR) systems, with 1548 reports analyzed, highlighting the importance of monitoring safety in MR imaging.

The most common serious injuries reported were thermal events, accounting for 59% of cases, followed by mechanical events (11%), projectile events (9%), and acoustic events (6%), indicating specific risks associated with MR environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-related FDA adverse event reports: A 10-yr review. Delfino, JG., Krainak, DM., Flesher, SA., et al.[2020]

In a study of 72,839 patients undergoing gadolinium-enhanced cardiac magnetic resonance imaging, the incidence of acute adverse events (AAEs) was low at 0.36%, with severe AAEs occurring in only 0.033% of cases.

AAE rates were influenced by factors such as the type of gadolinium-based contrast agent used, the presence of pharmacological stress during imaging, and the specific indications for the imaging, with higher rates observed during stress imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. Uhlig, J., Lücke, C., Vliegenthart, R., et al.[2021]

In a study of 1334 cardiovascular magnetic resonance (CMR) procedures for patients with congenital heart disease, the overall incidence of adverse events (AEs) was low at 1.6%, with most being minor in severity.

The use of general anesthesia and the status of being an inpatient were identified as independent risk factors for experiencing AEs, particularly in the most critically ill patients, highlighting the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. Dorfman, AL., Odegard, KC., Powell, AJ., et al.[2013]

In a study involving 148,489 patients over 10 years, gadoteric acid (Dotarem®) was found to be a safe MRI contrast agent, with only 0.3% of patients experiencing adverse events, primarily mild symptoms like nausea and vomiting.

The diagnostic effectiveness was high, with 99.8% of examinations yielding useful results and excellent or good image quality in 97.7% of cases, indicating that gadoteric acid is effective for routine MRI procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. Braun, J., Busse, R., Darmon-Kern, E., et al.[2020]

Gadopentetate dimeglumine (Gd-DTPA) has been safely used in over 45 million MRI procedures since its introduction in 1988, with adverse events (AEs) reported in less than 0.01% of cases, indicating a strong safety profile.

The analysis revealed that while serious AEs accounted for only 9.3% of reports, there were significant regional differences in AE reporting, with the U.S. reporting nearly double the AEs compared to Europe, highlighting the importance of ongoing pharmacovigilance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Knopp, MV., Balzer, T., Esser, M., et al.[2015]

Recent advancements in magnetic resonance imaging (MRI) include high-resolution techniques that allow for clearer images and better diagnosis, utilizing multiecho-multislice methods and special purpose coils.

These developments enhance various imaging capabilities, such as flow imaging and heart gating, and expand the use of MRI in spectroscopy, improving its overall efficacy in medical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the frontiers of magnetic resonance imaging. Hinds, LM.[2018]

High-resolution MRI using T2-weighted sequences allows for detailed visualization of the inner ear and auditory nerve structures, enabling the identification of conditions like aplasia or schwannoma in a quick imaging time of under 20 minutes.

In a study of 45 subjects, the MRI findings correlated well with intraoperative results in patients receiving cochlear implants, demonstrating the technique's reliability for surgical planning and anatomical assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Submillimeter imaging and reconstruction of the inner ear. Dahm, MC., Mack, MG., Tykocinski, M., et al.[2004]

Surface-coil techniques in MRI significantly enhance signal-to-noise ratio (SNR), allowing for smaller pixel sizes that improve image resolution beyond what conventional coils can achieve.

The successful use of surface-coil techniques opens up new avenues for both mathematical optimization of coil design and clinical research into high-resolution MRI applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High resolution magnetic resonance imaging using surface coils. Schenck, JF., Hart, HR., Foster, TH., et al.[2005]

Recent advancements in MRI technology, including better spatial resolution and new contrast agents, have made it a valuable tool for studying developmental processes.

Contrast agent-enhanced MRI offers novel applications in biological research, enhancing our ability to investigate various aspects of development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging contrast agents in the study of development. Louie, A.[2005]

Recent advancements in MRI technology focus on improving scanner hardware, particularly magnets and gradient units, which are crucial for enhancing imaging quality.

The chapter emphasizes the importance of radio frequency (rf) hardware in MRI, suggesting that custom-built devices can significantly improve imaging outcomes if properly implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scanner components. Behr, VC.[2011]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical assessment of MR of the brain in nonsurgical inpatients. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Enhancing same-day access to magnetic resonance imaging. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Independent spinal cord atrophy measures correlate to motor and sensory deficits in individuals with spinal cord injury. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of team training on improving MRI study completion rates and no-show rates. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Measuring the value of MRI: Comparative effectiveness & outcomes research. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

MRI-related FDA adverse event reports: A 10-yr review. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Exploring the frontiers of magnetic resonance imaging. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Submillimeter imaging and reconstruction of the inner ear. [2004]

13. United States pubmed.ncbi.nlm.nih.gov

High resolution magnetic resonance imaging using surface coils. [2005]

14. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging contrast agents in the study of development. [2005]

15. United States pubmed.ncbi.nlm.nih.gov

Scanner components. [2011]