NCT04685044

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 20, 2023

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

November 9, 2020

Last Update Submit

March 17, 2023

Conditions

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Qualitative equivalence or improvement of MRI image quality relative to the current mMR

    1 year

Study Arms (1)

Healthy Volunteers

OTHER

BrainPET insert

Device: IH 1Tx32Rx Head Array

Interventions

IH 1Tx32Rx Head ArrayDEVICE

BrainPET insert

Healthy Volunteers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Contraindications to MRI procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Health Care, London

London, Ontario, N6A 4V2, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

December 28, 2020

Study Start

November 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 20, 2023

Record last verified: 2022-08

Locations

CA(1)