NCT01757730

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Mar 2012Mar 2028

Study Start

First participant enrolled

March 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

16 years

First QC Date

December 18, 2012

Last Update Submit

April 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Any participant 18 years or older and are MR safe.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (5)

  • 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.

MeSH Terms

Conditions

Heart FailureLiver CirrhosisAortic Aneurysm

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAneurysmVascular DiseasesAortic Diseases

Study Officials

  • Arunark Kolipaka, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin L Thompson, B.S.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 18, 2012

First Posted

December 31, 2012

Study Start

March 1, 2012

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 6, 2025

Record last verified: 2025-04

Locations