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Magnetic Resonance Imaging Using Innovative Pulse Sequences

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01724216
First received: November 7, 2012
Last updated: October 15, 2015
Last verified: October 2015
History of Changes
  Purpose
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 Intervention
Clinical Indication for a Head MRI
 Device: pulse sequences

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Magnetic Resonance Imaging Using Innovative Pulse Sequences

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Number of Head Images Successfully Collected [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.
Enrollment: 11
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01724216     History of Changes
Other Study ID Numbers: 114-2012-GES-0014 
Study First Received: November 7, 2012
Results First Received: October 22, 2013
Last Updated: October 15, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 28, 2016