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

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

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
United States, Michigan | |
Spectrum Health | |
Grand Rapids, Michigan, United States, 49503 |
Principal Investigator: | Mark C DeLano, MD | Spectrum Health Hospitals |
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 |