Magnetic Resonance Imaging Using Innovative Pulse Sequences

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by GE Healthcare
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01724216
First received: November 7, 2012
Last updated: November 8, 2012
Last verified: October 2012
  Purpose

The purpose of the study is to collect in vivo human image data to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequences.


Condition Intervention
Head Images With and Without Contrast
Device: Magnetic Resonance Imaging Using Innovative 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:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Head Images [ 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.


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm Device: Magnetic Resonance Imaging Using Innovative Pulse Sequences

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Nancy Dekoff, CRN 616-391-9365 nancy.dekoff@spectrumhealth.org
Contact: Kim McClain, CRN 616-391-2883 kimberly.mcclain@spectrumhealth.org

Locations
United States, Michigan
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Nancy Dekoff, CRN    616-391-9365    nancy.dekoff@spectrumhealth.org   
Contact: Kim McClain, CRN    616-391-2883    kimberly.mcclain@spectrumhealth.org   
Principal Investigator: Mark C DeLano, MD         
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: Mark C DeLano, MD Spectrum Health Hospitals
  More Information

No publications provided

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
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 24, 2014