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Assessment of Investigational Magnetic Resonance Imaging and Post-Processing Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490656
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Michael V. Knopp MD, PhD, Ohio State University

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.

Condition or disease Intervention/treatment Phase
MRI Imaging Diagnostic Test: MRI Scan - in addition to standard of care Diagnostic Test: MRI Scan - not in addition to standard of care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Investigational Magnetic Resonance Imaging and Post-Processing Procedures
Actual Study Start Date : October 21, 2016
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Image quality [ Time Frame: through study completion, an average of 1-3 years ]
    assessed by blinded readers

  2. Artifacts [ Time Frame: through study completion, an average of 1-3 years ]
    assessed by blinded readers

  3. Lesion detectability [ Time Frame: through study completion, an average of 1-3 years ]
    assessed by blinded readers

  4. Image noise [ Time Frame: through study completion, an average of 1-3 years ]
    assessed region of interest over target tissue and background



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490656


Contacts
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Contact: Melanie Hughes 614-293-9998 office@wcibmi.org
Contact: Michael V Knopp, MD, PhD 614-293-9998 knopp.16@osu.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Michael V Knopp, MD, PhD    614-293-9998    knopp.16@osu.edu   
Sub-Investigator: Xiangyu Yang, PhD         
Sub-Investigator: Jun Zhang, PhD         
Sub-Investigator: Peter P Stanich, MD         
Sub-Investigator: Subha V Raman, MD         
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Michael V Knopp, MD, PhD Ohio State University
  Study Documents (Full-Text)

Documents provided by Michael V. Knopp MD, PhD, Ohio State University:
Study Protocol  [PDF] December 13, 2017


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Responsible Party: Michael V. Knopp MD, PhD, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03490656    
Other Study ID Numbers: RP0688/2013H0304
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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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