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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00739518
Recruitment Status : Enrolling by invitation
First Posted : August 21, 2008
Last Update Posted : May 18, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Nervous System Diseases Procedure: MRI

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Refinement and Assessment of New Magnetic Resonance Imaging (MRI) Technologies
Study Start Date : October 2004
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739518


Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
General Electric
Philips Medical Systems
Investigators
Principal Investigator: Ashok Srivinasan, MD University of Michigan
More Information

Responsible Party: Ashok Srinivasan, M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00739518     History of Changes
Other Study ID Numbers: HUM00041731
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ashok Srinivasan, M.D., University of Michigan:
Neurological
MRI

Additional relevant MeSH terms:
Nervous System Diseases