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

This study is currently recruiting participants.
Verified September 2013 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Arunark Kolipaka, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01757730
First received: December 18, 2012
Last updated: September 5, 2013
Last verified: September 2013

December 18, 2012
September 5, 2013
March 2012
December 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01757730 on ClinicalTrials.gov Archive Site
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Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
  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.
  • Heart Failure
  • Liver Fibrosis
  • Cardiac Transplant Rejection
  • Aortic Aneurysms
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2016
December 2016   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
Yes
Contact: Arunark Kolipaka 6143660268 arunark.kolipaka@osumc.edu
United States
 
NCT01757730
2012H0027
Yes
Arunark Kolipaka, The Ohio State University
Arunark Kolipaka
Not Provided
Principal Investigator: Arunark Kolipaka, PhD The Ohio state University Wexner Medical Center
Ohio State University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP