MRI Assessing Clinical Usability of STrategically Acquired Gradient Echo on Human Participants

Summary

The study's purpose is to validate STAGE images and, when applicable, their equivalence to conventional MRI through an assessment by a trained certified neuroradiologist in a clinical setting. For STAGE images without conventional equivalent, the neuroradiologist will determine if their contrasts, intensities, and quality are sufficient and meet expectations for images used in radiological reads of the brain. The study is a multi-center study in which STAGE can be assessed at sites with different MRI manufacturers and field strengths. Site names will be made available to the collaborators and participants. The sponsor is based out of Michigan, while participating sites may be located in other states. Any funding for the study will come from an industry source, SpinTech, Inc.

Conditions

• MRI

Interventions

DEVICE

STrategically Acquired Gradient Echo (STAGE)

The STAGE package uses conventional 3D gradient echo MR, its magnitude and phase, collected at set parameters which allow for the reconstruction of multiple MR datasets which results in decreased acquisition time, equivalency to conventional MR, and the decrease in scan time allows for a higher standard of wealth within the data acquired.

Sponsors & Collaborators

• Summit Medical Center

  collaborator OTHER

• Center for Diagnostic Imaging

  collaborator OTHER

• Loma Linda University

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• University of Massachusetts, Worcester

  collaborator OTHER

• SpinTech, Inc.

  lead OTHER

Principal Investigators

• Douglas P Beall, MD · Summit Medical Center

• Murray A Solomon, MD · Center for Diagnostic Imaging

• Vincent Magnotta, MD · University of Iowa

• Karen Tong, MD · Loma Linda University Health

• Frank Yu, MD · University of Texas

• Letterio Politi, MD · University of Massachusetts, Worcester

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-06-30

Primary Completion

2021-01-07

Completion

2021-01-07

FDA Device

Yes

Countries

• United States

Study Locations