Magnetic Resonance Imaging Using Innovative Pulse Sequences

Not Applicable

Completed

• Conditions: Clinical Indication for a Head MRI
• Interventions: Device: pulse sequences

• Registration Number: NCT01724216
• Lead Sponsor: GE Healthcare

Brief Summary

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

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-08
• Study First Posted: 2012-11-09
• Primary Completion: 2013-02
• Study Completion: 2013-04
• Results First Submitted: 2013-10-22
• Results First Submitted QC: 2014-08-25
• Results First Posted: 2014-09-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pulse sequence software	pulse sequences	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States