Testing a 32-channel Transmit/Receive MRI Head Array

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Magnetic Resonance Imaging
• Intervention / Treatment: Device: IH 1Tx32Rx Head Array

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Health Care, London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Volunteers; BrainPET insert	Device: IH 1Tx32Rx Head Array; BrainPET insert

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 114960

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No