Magnetic Resonance Imaging Using Innovative Pulse Sequences

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.

Study Overview

• Status: Completed
• Conditions: Clinical Indication for a Head MRI
• Intervention / Treatment: Device: 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

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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	Device: pulse sequences; Collect in vivo human data to demonstrate neurological Magnetic Resonance Imaging of subjects using a pulse sequence; Other Names: zero TE pulse sequences

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Head Images Successfully Collected	Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.	6-months

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Mark C DeLano, MD, Spectrum Health Hospitals

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 8, 2012
• First Posted (ESTIMATE): November 9, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 18, 2015
• Last Update Submitted That Met QC Criteria: October 15, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 114-2012-GES-0014