General Investigative MRI Protocol

February 4, 2013 updated by: Toshiba America Medical Systems, Inc.

General Investigational Protocol for EXCELART VANTAGE ZGV/XGV/AGV/ ATLAS/XGV/ZGV TITAN/XGV VANTAGE TITAN 3T

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Steinberg Diagnostic Medical Imaging
        • Contact:
        • Principal Investigator:
          • Mark L Winkler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
May 2012-May 2013

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toshiba America Medical Systems, Inc.

Investigators

  • Principal Investigator: Mark L Winkler, MD, Steinberg Diagnostic Medical Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ANTICIPATED)

May 1, 2013

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

May 11, 2012

First Submitted That Met QC Criteria

May 11, 2012

First Posted (ESTIMATE)

May 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 05069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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