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Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues (MRE)

This study is currently recruiting participants.
Verified September 2016 by Arunark Kolipaka, The Ohio State University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757730
First Posted: December 31, 2012
Last Update Posted: September 27, 2016
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.
Information provided by (Responsible Party):
Arunark Kolipaka, The Ohio State University
  Purpose
Magnetic resonance elastography is a novel non-invasive MRI technique to obtain stiffness of soft tissues such as liver, heart, kidneys, etc. In this imaging technique a person is laid in an MR scanner and a paddle (plastic drum) is put on the area of interest to send sound vibration via a speaker placed outside the scan room which is connecting plastic drum via a plastic tube. These vibrations are scanned using MRI to estimate the stiffness of soft tissues such as liver, heart, kidneys, breast etc.

Condition
Heart Failure Liver Fibrosis Cardiac Transplant Rejection Aortic Aneurysms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues

Further study details as provided by Arunark Kolipaka, The Ohio State University:

Primary Outcome Measures:
  • Stiffness of soft tissues [ Time Frame: Participants will be followed for the duration of hospital stay, ecah clinical visit after discharge for an expected average up to 1 year ]

Estimated Enrollment: 500
Study Start Date: March 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Altered Stiffness
Tissue stiffness will be evaluated in subjects those with disease conditions where stiffness changes from normal. These studies will be repeated for reproducibility.
Healthy Volunteers
Tissue stiffness will be evaluated in normal subjects to determine the normal values. These studies will be repeated for reproducibility.

Detailed Description:
Recently a new and novel noninvasive imaging-based technique known as Magnetic Resonance Elastography (MRE) was developed that is capable of quantifying stiffness of soft tissues such as liver, spleen, kidney, heart brain, breast, aorta etc. In MRE a person is laid into an MR scanner which is similar to all MR scans. In addition, a drum (passive driver) is placed on the body (area close to the region of interest), which is connected by a long plastic tube that runs outside the scan room. This drum is tightly strapped by a Velcro to the body for better contact. Then the other end of the plastic tube is connected to an active driver that produces vibrations of frequencies in the range of 20Hz -2kHz. These frequencies of vibrations are transferred to the passive driver which produces vibrations on the body. These vibrations are tracked using MR scanner to produce wave images. A post-processing of these wave images are performed to obtain spatial stiffness maps. Currently, MRE is a clinical tool to assess hepatic fibrosis at many institutions. MRE is superior to many invasive techniques (i.e. biopsies, catheter based Pressure-Volume measurements) and mechanical testing in that it is noninvasive and can be performed in vivo under physiologic conditions. MRE could make stiffness widely available and could revolutionize the diagnosis and treatment of numerous diseases affecting stiffness of soft tissues. For example in Liver: diagnosis of hepatic fibrosis, Non-alcoholic fatty liver disease, liver tumors etc. Heart: diagnosis of diastolic dysfunction, myocardial infarction, hypertrophic cardiomyopathy, contractility etc. Aorta: Aortic aneurysms, hypertension etc. This technology is completely noninvasive and the vibrational energy is way below the required standards. Previous experiences of these vibrations are like massaging the body. The risks of this research study are minimal, which means that we do not believe that they will be any different than what you would experience at a routine clinical visit or during your daily life. This study will not make participants' health better. It is for the benefit of research.The specific aim of this study is that MRE can be used as a noninvasive tool to diagnose different disease states in soft tissues. In this study we will be applying this technique in adult volunteers to test the feasibility and validation of the technique in different organs.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. You are 18 and over and affected by a certain disease condition such as Heart/Kidney/Lung/liver/spleen or aortic aneurysms or any other kind of diseases where stiffness of the soft tissue is thought to change.
  2. You are 18 and over and a healthy volunteer and not affected by any of the conditions mentioned in #1 above.
Criteria

Inclusion Criteria:

Any participant 18 years or older and are MR safe.

Exclusion Criteria:

That study participants will be excluded if they have any unapproved metal in their bodies, or if the volunteers are pregnant or possible of becoming pregnant. Also if the participants are claustrophobic.

  Contacts and Locations
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): NCT01757730


Contacts
Contact: Arunark Kolipaka 6143660268 arunark.kolipaka@osumc.edu

Locations
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Sarah Lawson    614-366-5429    Sarah.Lawson@osumc.edu   
Principal Investigator: Arunark Kolipaka, PhD         
Sponsors and Collaborators
Arunark Kolipaka
Investigators
Principal Investigator: Arunark Kolipaka, PhD The Ohio state University Wexner Medical Center
  More Information

Publications:

Responsible Party: Arunark Kolipaka, Assistant Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01757730     History of Changes
Other Study ID Numbers: 2012H0027
First Submitted: December 18, 2012
First Posted: December 31, 2012
Last Update Posted: September 27, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Heart Failure
Aneurysm
Aortic Aneurysm
Liver Cirrhosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aortic Diseases
Liver Diseases
Digestive System Diseases