Testing a 32-channel Transmit/Receive MRI Head Array

Not Applicable

• Conditions: Magnetic Resonance Imaging
• Interventions: Device: IH 1Tx32Rx Head Array

• Registration Number: NCT04685044
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Status Verified: 2022-08
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-20
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 18-75 years old
• Must be able to give consent
• Must complete the MRI screening questionnaire

Exclusion Criteria

• Contraindications to MRI procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	IH 1Tx32Rx Head Array	BrainPET insert

Primary Outcome Measures

Name	Time	Method
Quantitative equivalence or improvement of MRI image quality relative to the current mMR Array	1 year	(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

Secondary Outcome Measures

Name	Time	Method
Qualitative equivalence or improvement of MRI image quality relative to the current mMR	1 year	(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.

Trial Locations

Locations (1)

St. Joseph's Health Care, London; 🇨🇦 London, Ontario, Canada