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Magnetic Resonance Imaging Using Innovative Pulse Sequences
This study has been completed.
Sponsor:
GE Healthcare
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
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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:
Further study details as provided by GE Healthcare:
Primary Outcome Measures:
- 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.
| 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) |
| 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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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
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 |
ClinicalTrials.gov processed this record on June 28, 2017