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

Sponsor
Arunark Kolipaka (Other)
Overall Status
Recruiting
CT.gov ID
NCT01757730
Collaborator
(none)
1,000
1
162
6.2

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
    Study Start Date :
    Mar 1, 2012
    Anticipated Primary Completion Date :
    Sep 1, 2025
    Anticipated Study Completion Date :
    Sep 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Stiffness of soft tissues [Participants will be followed for the duration of hospital stay, ecah clinical visit after discharge for an expected average up to 1 year]

      Estimate any variation in stiffness

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Arunark Kolipaka

    Investigators

    • Principal Investigator: Arunark Kolipaka, PhD, The Ohio State University Wexner Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arunark Kolipaka, Associate Professor, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT01757730
    Other Study ID Numbers:
    • 2012H0027
    First Posted:
    Dec 31, 2012
    Last Update Posted:
    Apr 22, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2022