Comparison of MR Elastography Methods Without and With Compressed Sensing

Liver Diseases Clinical Trial

Official title:

Comparison of MR Elastography Methods Without and With Compressed Sensing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260660
• Other study ID #: CIN_CompMRE_001
• Status: Completed
• Phase: N/A
• First received: August 14, 2017
• Last updated: January 25, 2018
• Start date: August 15, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: January 2018
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Device:
• Magnetic Resonance Elastography
The investigators plan to prospectively assess the agreement of liver stiffness measurements obtained using standard of care MR elastography techniques vs. MR elastography with varying amounts of imaging acceleration using compressed sensing in adult volunteers

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x1.5)	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.	30 minutes
Primary	Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x2)	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.	30 minutes
Primary	Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x3)	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.	30 minutes
Secondary	Standard Magnetic Resonance Elastography versus respiratory triggered Magnetic Resonance Elastography.	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.	30 minutes
Secondary	Standard Magnetic Resonance Elastography versus navigated triggered Magnetic Resonance Elastography.	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.	30 minutes