- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01757730
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues (MRE)
October 23, 2023 updated by: Arunark Kolipaka
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.
Study Overview
Status
Recruiting
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 Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arunark Kolipaka
- Phone Number: 614-366-0268
- Email: arunark.kolipaka@osumc.edu
Study Contact Backup
- Name: Kristin L Thompson, B.S.
- Phone Number: 614-366-5429
- Email: Kristin.Thompson@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University Wexner Medical Center
-
Contact:
- Kristin L Thompson, B.S.
- Phone Number: 614-366-5429
- Email: Kristin.Thompson@osumc.edu
-
Principal Investigator:
- Arunark Kolipaka, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
- 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.
- You are 18 and over and a healthy volunteer and not affected by any of the conditions mentioned in #1 above.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Estimate any variation in stiffness
|
Participants will be followed for the duration of hospital stay, ecah clinical visit after discharge for an expected average up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arunark Kolipaka, PhD, The Ohio State University Wexner Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Damughatla AR, Raterman B, Sharkey-Toppen T, Jin N, Simonetti OP, White RD, Kolipaka A. Quantification of aortic stiffness using MR elastography and its comparison to MRI-based pulse wave velocity. J Magn Reson Imaging. 2015 Jan;41(1):44-51. doi: 10.1002/jmri.24506. Epub 2013 Nov 15.
- Chamarthi SK, Raterman B, Mazumder R, Michaels A, Oza VM, Hanje J, Bolster B, Jin N, White RD, Kolipaka A. Rapid acquisition technique for MR elastography of the liver. Magn Reson Imaging. 2014 Jul;32(6):679-83. doi: 10.1016/j.mri.2014.02.013. Epub 2014 Feb 13.
- Kenyhercz WE, Raterman B, Illapani VS, Dowell J, Mo X, White RD, Kolipaka A. Quantification of aortic stiffness using magnetic resonance elastography: Measurement reproducibility, pulse wave velocity comparison, changes over cardiac cycle, and relationship with age. Magn Reson Med. 2016 May;75(5):1920-6. doi: 10.1002/mrm.25719. Epub 2015 Jun 12.
- Wassenaar PA, Eleswarpu CN, Schroeder SA, Mo X, Raterman BD, White RD, Kolipaka A. Measuring age-dependent myocardial stiffness across the cardiac cycle using MR elastography: A reproducibility study. Magn Reson Med. 2016 Apr;75(4):1586-93. doi: 10.1002/mrm.25760. Epub 2015 May 22.
- Moldovan L, Anghelina M, Kantor T, Jones D, Ramadan E, Xiang Y, Huang K, Kolipaka A, Malarkey W, Ghasemzadeh N, Mohler PJ, Quyyumi A, Moldovan NI. A module of human peripheral blood mononuclear cell transcriptional network containing primitive and differentiation markers is related to specific cardiovascular health variables. PLoS One. 2014 Apr 23;9(4):e95124. doi: 10.1371/journal.pone.0095124. eCollection 2014. Erratum In: PLoS One. 2014;9(7):e104595.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
December 18, 2012
First Submitted That Met QC Criteria
December 21, 2012
First Posted (Estimated)
December 31, 2012
Study Record Updates
Last Update Posted (Actual)
October 24, 2023
Last Update Submitted That Met QC Criteria
October 23, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012H0027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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