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Completed

NCT Number: NCT03260660

Comparison of MR Elastography Methods Without and With Compressed Sensing

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.

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Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Resonance Elastography

Device

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

Primary outcomes

  1. Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x1.5)

    Time frame: 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.

  2. Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x2)

    Time frame: 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.

  3. Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x3)

    Time frame: 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 outcomes

  1. Standard Magnetic Resonance Elastography versus respiratory triggered Magnetic Resonance Elastography.

    Time frame: 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.

  2. Standard Magnetic Resonance Elastography versus navigated triggered Magnetic Resonance Elastography.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2017
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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