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

Completed · Not applicable

Conditions studied: MRI

In brief

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.

Key facts

Study ID

NCT04292301

Run by

SpinTech, Inc.

People needed

92

Starts

2020-06-30

Expected to finish

2021-01-07

Last updated by the study team

2022-06-28

Who can join

Age: 6 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects 6-80 years of age, inclusive.
• Literate in English
• No contraindications to MR
• Not claustrophobic

You may not qualify if…

• Subject has diffuse white matter disease or leukoaraiosis.
• Participant, or if participant is under 18 years of age, participant's parent or guardian unable to read and sign an informed consent.
• Women who are pregnant or breast-feeding.
• Those with major surgery within the past eight weeks or scheduled surgery within 30 days.
• Chronic back pain or inability to lie still for 5 minutes or more.
• History of drug or alcohol abuse.
• Individuals who exceed 28 BMI or 320 lbs.
• Individual whose girth exceeds the magnetic bore.
• Direct employee or student of the PI.
• Participants belong to a vulnerable group.

Where it is running

• Loma Linda University Health — Loma Linda, California, United States
• Insight Imaging - Center for Diagnostic Imaging — Los Gatos, California, United States
• University of Iowa — Iowa City, Iowa, United States
• Summit Medical Center — Edmond, Oklahoma, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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