Assessment of Investigational Magnetic Resonance Imaging and Post-Processing Procedures

NCT ID: NCT03490656

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-21
• Study Completion Date: 2024-12-31

Brief Summary

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.

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.

Conditions

MRI Imaging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy volunteer population

Group Type: EXPERIMENTAL

MRI Scan - not in addition to standard of care

Intervention Type: DIAGNOSTIC_TEST

Up to 3 Tesla (T) MRI

Patient population

Group Type: EXPERIMENTAL

MRI Scan - in addition to standard of care

Intervention Type: DIAGNOSTIC_TEST

Up to 3 Tesla (T) MRI

Interventions

MRI Scan - in addition to standard of care

Up to 3 Tesla (T) MRI

Intervention Type: DIAGNOSTIC_TEST

MRI Scan - not in addition to standard of care

Up to 3 Tesla (T) MRI

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Michael V Knopp MD PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael V Knopp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

RP0688/2013H0304

Identifier Type: -

Identifier Source: org_study_id