Assessment of Investigational Magnetic Resonance Imaging and Post-Processing Procedures



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:5/20/2018
Start Date:October 21, 2016
End Date:February 15, 2022
Contact:Melanie Hughes
Email:office@wcibmi.org
Phone:614-293-9998

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The goals of this study are to (1) develop and optimize MRI acquisition and post-processing
techniques and (2) to generate preliminary and comparative data on sequences for potential
clinical trials.

This prospective study will utilize investigational MRI sequences both in a volunteer
population as well as in patients in addition to standard of care MR imaging to develop and
optimize MRI sequence post-processing techniques as well as to generate preliminary and
comparative data for potential clinical trials. These post-processing techniques include but
are not limited to visual inspection of image quality and known anatomy, semi-quantitative
analysis including the use of rating schemes, signal-to-noise-ratios and
contrast-to-noise-ratios measurements for quantitative assessment, standard fitting
procedures for measuring MRI parameters, and using various published methods for image
post-processing. The MRI methodologies we plan to use as part of this study will allow us to
obtain morphological, functional and molecular information. For the patient population:
Patients receiving a standard of care 1.5 or 3T MRI will be asked by study personnel if they
are interested in undergoing additional investigational imaging sequences after their
standard of care imaging. If the patient agrees, he/she will remain in the same position on
the MRI scanner for up to an additional 30 minutes while more images are obtained. Each
patient will be imaged for no longer than 2 hours (standard of care imaging and additional
investigational imaging). A routine clinical report will be generated for the clinically
indicated MRI by a radiologist. Once this routine clinical MRI scan is dictated and
finalized, a study team member will obtain the report via IHIS and manually remove all
identifiers. This report is being obtained for comparative purposes. All the data being
compared will be coded using a unique study number. For the volunteer population: Healthy
volunteers recruited through the OSU Wexner Medical Center or accompanying patients to their
standard of care imaging appointments at The Wright Center of Innovation will be asked by
study personnel if they are interested in undergoing investigational MR imaging sequences. If
the volunteer agrees, he/she will be imaged on the MRI scanner for up to 60 minutes while
images are obtained. Other than the participant signing the informed consent form, no
participant information or protected health information (PHI) will be recorded. Following the
informed consent authorization, the participant's name will be coded using a unique study
number.

Inclusion Criteria:

- Male and female volunteers greater than or equal to 18 years of age

- Patients receiving a standard of care 1.5 or 3T MRI at The Ohio State University

- Healthy volunteers that feel comfortable receiving an investigational mRI

Exclusion Criteria:

- Participants with a contraindication to MRI. Such contraindications include, but are
not limited to: pacemaker, metallic cardiac valve(s), magnetic material such as
surgical clips, tattoos, implanted electronic infusion pumps or any other condition
that would interfere with the MRI, a stent somewhere, a history of allergic reaction
to any metals

- Participants that experience claustrophobia, anxiety and/or vertigo when moved inside
the scanner

- Participants with vital signs outside of normal range

- Prisoners

- Subjects incapable of giving informed written consent

- Participants who are pregnant, healthy volunteers
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-293-9998
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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mi
from
Columbus, OH
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