Magnetic Resonance Imaging Using Innovative Pulse Sequences

General Electric (GE)

Status: Completed

Conditions: Clinical Indication for a Head MRI

Treatments: Device: pulse sequences

Study type: Interventional

Funder types: Industry

Identifiers

NCT01724216

114-2012-GES-0014

Details and patient eligibility

About

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.

Full 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

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

11 participants in 1 patient group

pulse sequence software

Experimental group

Description:

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

Treatment:

Device: pulse sequences