General Investigative MRI Protocol

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01598766
Recruitment Status : Recruiting
First Posted : May 15, 2012
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):
Toshiba America Medical Systems, Inc.

Brief Summary:
This study is a feasibility study to evaluate new technology to improve the MRI experience, with coils, sequences and software. Patients from the Principle Investigator's exam schedule are given the opportunity to participate in this study is their MRI exam is appropriate for the specific coil, sequence or software being evaluated. If they agree, they can receive their MRI exam with the new coil, sequence or software instead of the standard one.

Condition or disease Intervention/treatment Phase
Multiple MRI Exams, Including Cardiac Abdominal Lumbar Neck Pelvis Device: 16 Channel SPEEDER Flex Coil Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: General Investigational Protocol for EXCELART VANTAGE ZGV/XGV/AGV/ ATLAS/XGV/ZGV TITAN/XGV VANTAGE TITAN 3T
Study Start Date : May 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: Diagnostic Coil
This coil is a lightweight, flexible coil which can be used for many pediatric MRI exams
Device: 16 Channel SPEEDER Flex Coil
This is a 16 element MRI coil, flexible, lightweight. Multiple uses.

Primary Outcome Measures :
  1. 16 Channel Flex Coil [ Time Frame: May 2012-May 2013 ]
    The 16 Channel Flex Coil will be evaluated for how well it performs on pediatric patients.

Secondary Outcome Measures :
  1. 8 Channel Value Breast Coil [ Time Frame: 6 months ]
    clinical evaluation to determine if an 8 channel mri breast coil meets industry standards.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Pediatric patients that are scheduled for a clinically necessary MRI exam provided the subject meets the criteria of the department MRI screening procedure and their study is appropriate for the use of the 4 Channel Flex SPEEDER coil of the 16 Channel Metaflex SPEEDER coil.

Exclusion Criteria:

  • Any contraindication to MRI procedures

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 identifier (NCT number): NCT01598766

Contact: Erin Kelly 7146046242

United States, Nevada
Steinberg Diagnostic Medical Imaging Recruiting
Henderson, Nevada, United States, 89052
Contact: Erin Kelly, PhD    714-604-6242   
Principal Investigator: Mark L Winkler, MD         
Sponsors and Collaborators
Toshiba America Medical Systems, Inc.
Principal Investigator: Mark L Winkler, MD Steinberg Diagnostic Medical Imaging

Responsible Party: Toshiba America Medical Systems, Inc. Identifier: NCT01598766     History of Changes
Other Study ID Numbers: 05069
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013