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Magnetic Resonance Imaging Using Innovative Pulse Sequences

NCT ID: NCT01724216

Last Updated: 2015-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Clinical Indication for a Head MRI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

pulse sequences

Intervention Type DEVICE

Collect in vivo human data to demonstrate neurological Magnetic Resonance Imaging of subjects using a pulse sequence

Interventions

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pulse sequences

Collect in vivo human data to demonstrate neurological Magnetic Resonance Imaging of subjects using a pulse sequence

Intervention Type DEVICE

Other Intervention Names

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zero TE pulse sequences

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark C DeLano, MD

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Locations

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Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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114-2012-GES-0014

Identifier Type: -

Identifier Source: org_study_id