Refinement and Assessment of New Magnetic Resonance Imaging Technologies for Neurological Exams

March 11, 2021 updated by: Ashok Srinivasan, M.D., University of Michigan

Refinement and Assessment of New Magnetic Resonance Imaging (MRI) Technologies

This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine head and neck regions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine, and head & neck regions.

Software and hardware are constantly being improved, new machines replace old machines, software is updated and improved as are the devices used to produce better MRI images.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • If you are a male or a non-pregnant female patient
  • Normal volunteer
  • presenting to MRI for a clinically-ordered neurological or head and neck MRI exam

Exclusion Criteria:

  • Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
  • Pregnant patients or patients who are lactating.
  • A patient who is claustrophobic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MRI scan - new technology
The patient's clinical MRI scan will also utilize some new technology, such as a change in software or additional MRI sequences
Procedure: MRI
Neurological MRI with new technology evaluation. The new technology may involve software or MRI scanning sequences. This is a long term research study that focuses on new technology that is constantly being created.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in quality of MRI studies in Neuroradiology
Time Frame: 1 year

Specific Measurement Are:

  1. Scan speed - is the new method as fast or faster than regular method(s)
  2. Signal to noise - Subjectively, or quantitatively do we get the same, better, or new contrast compared to the regular methods(s).
  3. Image contrast - Subjectively, or quantitatively do we get the same or better resolution compared to the regular method(s).
  4. Spatial resolution - Subjectively, or quantitatively do we get the same or better resolution compared to the regular method(s).
  5. Artifact - Subjectively, or quantitatively do we get the better artifact reduction compared to the regular method(s).
  6. Ergonomics - Is the new software easier to work or offer more information more cleanly than the regular software
  7. Patient comfort - Subjectively, does the new software and/or hardware make the patient's MRI experience more comfortable.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

General Electric
Philips Medical Systems

Investigators

  • Principal Investigator: Ashok Srivinasan, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2004

Primary Completion (ACTUAL)

January 14, 2020

Study Completion (ACTUAL)

January 14, 2020

Study Registration Dates

First Submitted

August 20, 2008

First Submitted That Met QC Criteria

August 20, 2008

First Posted (ESTIMATE)

August 21, 2008

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00041731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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