General Investigative MRI Protocol

Overview

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.

Full Title of Study: “General Investigational Protocol for EXCELART VANTAGE ZGV/XGV/AGV/ ATLAS/XGV/ZGV TITAN/XGV VANTAGE TITAN 3T”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2013

Interventions

  • Device: 16 Channel SPEEDER Flex Coil
    • This is a 16 element MRI coil, flexible, lightweight. Multiple uses.

Arms, Groups and Cohorts

  • Experimental: Diagnostic Coil
    • This coil is a lightweight, flexible coil which can be used for many pediatric MRI exams

Clinical Trial Outcome Measures

Primary 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Toshiba America Medical Systems, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mark L Winkler, MD, Principal Investigator, Steinberg Diagnostic Medical Imaging
  • Overall Contact(s)
    • Erin Kelly, 7146046242, ekelly@tams.com

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