~3122 spots leftby Dec 2030

MRI Development Study

Recruiting in Palo Alto (17 mi)
Overseen ByRob Fraser, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: GE HealthCare Technologies Inc
Disqualifiers: Unhealthy, others
No Placebo Group
Approved in 1 jurisdiction

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.

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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.

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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.

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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?

Trial 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

Participant Groups

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.
1Treatment groups
Experimental Treatment
Group I: the studyExperimental Treatment1 Intervention
Patients with a PPM or ICD getting a clinically indicated MRI

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
GE HealthcareAurora, OH
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Who Is Running the Clinical Trial?

GE HealthCare Technologies IncLead Sponsor

References

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Enhancing same-day access to magnetic resonance imaging. [2019]The aim of this study was to provide better patient access to MRI within 24 hours through process improvement.
Independent spinal cord atrophy measures correlate to motor and sensory deficits in individuals with spinal cord injury. [2022]Cross-sectional descriptive analysis of magnetic resonance imaging (MRI) and clinical outcome.
Effect of team training on improving MRI study completion rates and no-show rates. [2018]Magnetic resonance imaging (MRI) is a high-cost imaging modality, and an optimized encounter ideally provides high-quality care, patient satisfaction, and capacity utilization. Our purpose was to assess the effectiveness of team training and its impact on patient show-up and completion rates for their MRI examinations.
Measuring the value of MRI: Comparative effectiveness & outcomes research. [2020]Magnetic resonance imaging (MRI) now provides diagnostic assessment for numerous clinical indications, including lesion detection, characterization, functional assessment, and response to treatment. To maximize the potential to improve health through the use of MRI, it is critical to investigate the impact of MRI on outcomes, and to compare the effectiveness of MRI with existing standard diagnostic approaches. Outcomes of MRI can include survival but also intermediate steps such as potential reduction in unnecessary therapy, shorter time to the appropriate therapy, or shorter periods of hospital admission. To understand the effectiveness of an imaging test's sensitivity and specificity, the results' consequences are weighed, reflecting the disease type, severity, and treatment effects. In some instances, other modalities may be faster, more readily available, or less costly than MRI but additional disease-related information or better accuracy may translate to greater population level benefit. For health policy decisions and clinical guidelines, studies of comparative outcomes can lend depth to the strength of the evidence, the specific benefits vs. harms of using one test over another, and the most effective use of the test in terms of target population. Cost effectiveness then allows for a direct comparison of approaches in terms of the cost for the projected gain in life expectancy and/or quality adjusted life expectancy. Expanding the literature on improved efficiency, accessibility, clinical effectiveness, and cost effectiveness will support the directive for better quality and value in healthcare. Level of Evidence 5 Technical Efficacy Stage 5 J. Magn. Reson. Imaging 2019.
MRI-related FDA adverse event reports: A 10-yr review. [2020]To provide an overview of the types of adverse events reported to the US Food and Drug Administration (US FDA) for magnetic resonance (MR) systems over a 10-yr period.
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]To assess the incidence of acute adverse events (AAEs) in gadolinium-enhanced cardiac magnetic resonance (CMR) imaging.
Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]To assess the incidence and severity of adverse events (AE) associated with cardiovascular magnetic resonance (CMR) in a large cohort of patients with congenital heart disease and to identify independent risk factors for their occurrence.
Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. [2020]Magnetic resonance imaging (MRI) examinations with intravenous (IV) contrast are performed worldwide in routine daily practice. In order to detect and enumerate even rare adverse events (AE) and serious adverse events (SAE), and to relate them with patients' baseline characteristics and diagnostic effectiveness, high quantity sample size is necessary.
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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]Although contrast agents have become indispensable tools in magnetic resonance and their safe and effective use the foundation of many essential diagnostic procedures, only limited summary information on their utilization and pharmacovigilance is available to the community. After voluntary access to the manufacturer spontaneous adverse event database, we assessed the available data for gadopentetate dimeglumine.
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Exploring the frontiers of magnetic resonance imaging. [2018]New developments in magnetic resonance imaging are highlighted, including multiecho-multislice high-resolution imaging, special purpose coils, multiplanar imaging, thin slices, hybrid imaging processing, flow imaging, heart gating, paramagnetic contrast material, and wider application of spectroscopy.
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Submillimeter imaging and reconstruction of the inner ear. [2004]To present new radiological developments using high-resolution magnetic resonance imaging (MRI).
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High resolution magnetic resonance imaging using surface coils. [2005]There is, of course, an intense activity directed at the improvement of MR imaging capabilities. Surface-coil techniques offer the possibility of improving the SNR sufficiently to permit the reduction of pixel sizes to values that would not be possible with conventional head and body coils. The successful application of surface-coil techniques to MR imaging suggests that this technique will be widely used in future MR imaging systems. This provides a fertile field for new research. This includes opportunities for mathematical and physical research into optimizing coil design. It also includes many opportunities for clinical research into the utilization of surface coils and high resolution MR imaging.
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Magnetic resonance imaging contrast agents in the study of development. [2005]The use of magnetic resonance imaging (MRI) as a research tool in the study of development has increased in recent years due in part to improvements in spatial resolution, new imaging agents, and increased availability of MRI scanners. This chapter describes how contrast agent-enhanced MRI can be used to study development. In addition, we highlight some novel applications of contrast agent-enhanced MRI in biology that may be useful as tools for the study of development.
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Scanner components. [2011]New developments in magnetic resonance imaging (MRI) are being achieved in two fields: methodological and technological innovations. This chapter will focus on the technological aspects of scanners, explain concepts, and give hints on how to deal with hardware-related issues. First, magnets used in MRI and gradient units will be introduced. Second, the radio frequency (rf) hardware will be described and explained. It has an often underestimated impact on imaging quality and can be improved by custom-built devices if one knows how to do it.