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General Investigative MRI Protocol

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2013 by Toshiba America Medical Systems, Inc.
Information provided by (Responsible Party):
Toshiba America Medical Systems, Inc. Identifier:
First received: May 11, 2012
Last updated: February 4, 2013
Last verified: February 2013
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 Intervention Phase
Multiple MRI Exams, Including Cardiac Abdominal Lumbar Neck Pelvis Device: 16 Channel SPEEDER Flex Coil Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Toshiba America Medical Systems, Inc.:

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

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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
  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 identifier: 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
  More Information

Responsible Party: Toshiba America Medical Systems, Inc. Identifier: NCT01598766     History of Changes
Other Study ID Numbers: 05069
Study First Received: May 11, 2012
Last Updated: February 4, 2013 processed this record on September 21, 2017