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Magnetic Resonance Imaging Using Innovative Pulse Sequences

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ClinicalTrials.gov Identifier: NCT01724216
Recruitment Status : Completed
First Posted : November 9, 2012
Results First Posted : September 2, 2014
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Description
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Brief Summary:
The purpose of the study is to collect in vivo human image data to demonstrate neurological magnetic resonance imaging (MRI) of subjects using short pulse sequences.

Condition or disease Intervention/treatment Phase
Clinical Indication for a Head MRI Device: pulse sequences Not Applicable

Detailed Description:
This is a single-site; open-label, prospective research Study involving human subjects. There will be no comparative efficacy or safety analysis and therefore no randomization

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Magnetic Resonance Imaging Using Innovative Pulse Sequences
Study Start Date : October 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : April 2013

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: pulse sequence software
The central aim of this study is to acquire a set of images and associated technical and clinical information to facilitate regulatory submission of the pulse sequences being studied by GEHC. Segment 1 allows to collect a minimum of 10 subjects then evaluate if additional scans/enrollment needed Segment 2 will allow an additional 90 subjects if data needed
 Device: pulse sequences
Collect in vivo human data to demonstrate neurological Magnetic Resonance Imaging of subjects using a pulse sequence
Other Name: zero TE pulse sequences


Outcome Measures
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Primary Outcome Measures :
  1. Number of Head Images Successfully Collected [ Time Frame: 6-months ]
    Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be at least 18 years of age
  • Subject must be willing and able to undergo verbal and written informed consent
  • Subject must have a clinical indication for a head MRI with and without Gadolinium-based contrast agent administration

Exclusion Criteria:

  • Subjects who have any of the conditions below at the time of the enrollment or scan session are excluded from this study. Further, should it be determined by study staff that an enrolled subject meets any of the conditions below during the course of the study, the subject will be removed from the study.

    • Any contraindication to an MRI scan per the policy of Spectrum Health
    • Any contraindication to administration of an MRI contrast agent per the policy of Spectrum Health
    • Off-label utilization of contrast agents administered for the subject's clinical exam
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01724216


Locations
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: Mark C DeLano, MD Spectrum Health Hospitals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01724216     History of Changes
Other Study ID Numbers: 114-2012-GES-0014
First Posted: November 9, 2012    Key Record Dates
Results First Posted: September 2, 2014
Last Update Posted: November 18, 2015
Last Verified: October 2015