Testing a 32-channel Transmit/Receive MRI Head Array

Study Overview
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Brief Summary
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Magnetic resonance imaging (MRI) is a diagnostic tool in medicine that generates high quality images of the human body without the use of x-rays. Volunteers will be asked to participate in a study to evaluate improved MRI hardware that can be used to enhance the ability of MRI as a diagnostic tool. Specifically, this hardware is designed to acquire high quality images of the brain. This MRI hardware will eventually be integrated into a positron emission tomography (PET) system, which will be able to detect trace amounts of brain disease and/or brain function simultaneously with MRI. The combined system is known as a PET/MRI. For the purposes of this test, the investigators are just evaluating the MRI hardware, which will be installed in a plastic mockup of the PET system.

Official Title
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Testing the IH 1Tx32Rx Head Array, a 32-channel Transmit/Receive Radiofrequency (RF) Array

Conditions
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Magnetic Resonance Imaging

Intervention / Treatment
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* Device: IH 1Tx32Rx Head Array


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old Must be able to give consent Must complete the MRI screening questionnaire Exclusion Criteria: Contraindications to MRI procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Volunteers<br>BrainPET insert | Device: IH 1Tx32Rx Head Array<br>* BrainPET insert<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative equivalence or improvement of MRI image quality relative to the current mMR Array | (i) Quantitative Analysis: MRI data will be acquired and analyzed to assess image homogeneity, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) for identical MRI pulse sequences acquired with each RF coil. In addition, we will assess quality parameters such as the g-factor and noise correlation coefficients of each coil for different acceleration factors in both phantoms and volunteers. Simple statistical tests like the paired Student's t-test will be applied to any metrics | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative equivalence or improvement of MRI image quality relative to the current mMR | (i) Qualitative Analysis: Trained readers will search for visually discernible artifacts, compare image quality (subjective measures of contrast, noise and resolution) and check whether the Tx/Rx Array will provide similar clinical diagnostic accuracy (sensitivity and specificity) to the mMR Array. | 1 year |