Assessment of Investigational Magnetic Resonance Imaging and Post-Processing Procedures

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.

Study Overview

• Status: Active, not recruiting
• Conditions: MRI Imaging
• Intervention / Treatment: Diagnostic test: MRI Scan - not in addition to standard of care; Diagnostic test: MRI Scan - in addition to standard of care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteer population	Diagnostic test: MRI Scan - not in addition to standard of care; Up to 3 Tesla (T) MRI
Experimental: Patient population	Diagnostic test: MRI Scan - in addition to standard of care; Up to 3 Tesla (T) MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality	assessed by blinded readers	through study completion, an average of 1-3 years
Artifacts	assessed by blinded readers	through study completion, an average of 1-3 years
Lesion detectability	assessed by blinded readers	through study completion, an average of 1-3 years
Image noise	assessed region of interest over target tissue and background	through study completion, an average of 1-3 years

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Michael V Knopp, MD, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2016
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RP0688/2013H0304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes