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Testing a 32-channel Transmit/Receive MRI Head Array

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04685044
Enrollment
15
Registered
2020-12-28
Start date
2020-11-01
Completion date
2023-12-31
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Resonance Imaging

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.

Interventions

DEVICEIH 1Tx32Rx Head Array

BrainPET insert

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Contraindications to MRI procedure

Design outcomes

Primary

MeasureTime frameDescription
Quantitative equivalence or improvement of MRI image quality relative to the current mMR Array1 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

MeasureTime frameDescription
Qualitative equivalence or improvement of MRI image quality relative to the current mMR1 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026