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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Collaborators:
General Electric
Philips Medical Systems
Information provided by (Responsible Party):
Ashok Srinivasan, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT00739518
First received: August 20, 2008
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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 always being improved, new machines replace old machines, software is updated and improved as well as devices used to produce better MRI images.


Condition Intervention
Nervous System Diseases
Procedure: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Improvement in quality of MRI studies in Neuroradiology [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 500
Study Start Date: October 2004
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
NEW technology MRI
Procedure: MRI
Neurological MRI with new technology evaluation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739518

Contacts
Contact: Ashok Srivinasan, MD 734 936-88254 ashoks@med.umich.edu

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ashok Srivinasan, MD    734-936-8865    ashoks@umich.edu   
Sponsors and Collaborators
University of Michigan
General Electric
Philips Medical Systems
  More Information

No publications provided

Responsible Party: Ashok Srinivasan, M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00739518     History of Changes
Other Study ID Numbers: HUM00041731
Study First Received: August 20, 2008
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Neurological
MRI

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on November 23, 2014