Testing a 32-channel Transmit/Receive MRI Head Array

Magnetic Resonance Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04685044
• Other study ID #: 114960
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-75 years old

• Must be able to give consent

• Must complete the MRI screening questionnaire

Exclusion Criteria:

• Contraindications to MRI procedure

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

Device:
• IH 1Tx32Rx Head Array
BrainPET insert

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care, London	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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