Clinical trial NCT01757730: Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Official title: Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Liver Fibrosis
Cardiac Transplant Rejection
Aortic Aneurysms
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Stiffness of soft tissues
timeFrame: Participants will be followed for the duration of hospital stay, ecah clinical visit after discharge for an expected average up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Arunark Kolipaka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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/jmri.24506. Epub 2013 Nov 15.
citation: 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.
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 relationship with age. Magn Reson Med. 2016 May;75(5):1920-6. doi: 10.1002/mrm.25719. Epub 2015 Jun 12.
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/mrm.25760. Epub 2015 May 22.
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 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.