An interventional study of MRI Scan - in addition to standard of care and MRI Scan - not in addition to standard of care in MRI Imaging, sponsored by University of Cincinnati. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
Diagnostic Test: MRI Scan - not in addition to standard of care
Diagnostic Test: MRI Scan - in addition to standard of care
Up to 3 Tesla (T) MRI
Up to 3 Tesla (T) MRI
Image quality
assessed by blinded readers
Time frame: through study completion, an average of 1-3 years
Artifacts
assessed by blinded readers
Time frame: through study completion, an average of 1-3 years
Lesion detectability
assessed by blinded readers
Time frame: through study completion, an average of 1-3 years
Image noise
assessed region of interest over target tissue and background
Time frame: through study completion, an average of 1-3 years
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This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of Cincinnati