Comparison of MR Elastography Methods Without and With Compressed Sensing

Completed

• Conditions: Liver Diseases

• Registration Number: NCT03260660
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

In this research study, the investigators will compare the liver stiffness results obtained from the current Magnetic Resonance Imaging (MRI) method to liver stiffness results obtained from a method that uses faster imaging techniques.

Detailed Description

MR elastography is increasingly used to assess liver stiffness in pediatric and adult patients with chronic liver diseases. While numerous tissue abnormalities can affect liver stiffness, liver stiffness measured by MR elastography is most often used to predict and quantify liver fibrosis. Conventional MR elastography techniques require multiple breath-holds that are 12-20 seconds in length. In the pediatric population, reliable breath-holding \>10 seconds can be challenging. Recently, compressed sensing has become available as a method for accelerating image data acquisition, and thus shortening breath-holds.

Study Timeline

• Study First Submitted: 2017-08-14
• Study Start: 2017-08-15
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-24
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Adult volunteers ≥18 years of age
• Ability to tolerate 30 minutes in an MRI scanner.
• Nothing to eat or drink for 4 hours prior to the MRI scan

Exclusion Criteria

• No contraindication to MR imaging (e.g., implanted non-MRI compatible device)
• Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x1.5)	30 minutes	Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 1.5 times the amount of standard Sensing applied. Correlation Coefficient will be determined for resulting elastography data.
Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x2)	30 minutes	Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 2 times the amount of standard sensing applied. correlation coefficient will be determined for resulting elastography data.
Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x3)	30 minutes	Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 3 times the amount of standard Sensing applied. Correlation coefficient will be determined for resulting elastography data.

Secondary Outcome Measures

Name	Time	Method
Standard Magnetic Resonance Elastography versus navigated triggered Magnetic Resonance Elastography.	30 minutes	Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography acquired using navigated triggered Gradient Recalled Elastography. Correlation coefficient will be determined for resulting elastography data.
Standard Magnetic Resonance Elastography versus respiratory triggered Magnetic Resonance Elastography.	30 minutes	Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography acquired using respiratory triggered Gradient Recalled Elastography. Correlation coefficient will be determined for resulting elastography data.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States