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

Heart Failure Clinical Trial

— MRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01757730
• Other study ID #: 2012H0027
• Status: Recruiting
• Start date: March 2012
• Est. completion date: October 1, 2026

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: Arunark Kolipaka
• Phone: 614-366-0268
• Email: arunark.kolipaka[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysms
• Cardiac Transplant Rejection
• Heart Failure
• Liver Cirrhosis
• Liver Fibrosis

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Arunark Kolipaka

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 F — View Citation

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/ — View Citation

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 relationshi — View Citation

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 differe — View Citation

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/m — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stiffness of soft tissues	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