Correlation of Ultrasound Based Measurements of Liver Stiffness and Steatosis With MRI

The investigators will assess the ability of ultrasound (US) to measure liver stiffness (cirrhosis) and liver fat content (steatosis).

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis; Liver Steatoses
• Intervention / Treatment: Diagnostic test: Ultrasound

Detailed Description

Non-invasive monitoring of liver fibrosis using magnetic resonance imaging (MRI) can help determine which patients will most benefit from interventional therapies to help reverse the condition. Similarly, quantitative assessment of liver fat content using MRI can assist physicians in identifying patients at risk for hepatic steatohepatitis.

Due to the widespread dissemination of US machines and their relative lower cost compared to other imaging modalities, e.g. MRI, the ability of US to assess these parameters widens diagnostic availability.

Patients who have undergone an MRI exam to assess liver stiffness (cirrhosis) and/or liver fat content (steatosis) will be asked to undergo an US exam to assess the same parameters. The cirrhosis and steatosis measurements obtained from both exams will be compared. If US-based measurements of liver stiffness and/or liver fat content are shown to be reproducible and accurate when compared to MRI values (will be used as the gold standard), US may become the first-line diagnostic test for these liver conditions.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
    • Stanford, California, United States, 94305
      • Stanford University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who have or are scheduled to undergo a routine clinical MRI at Stanford that included assessment of liver stiffness or liver fat content will be identified using the radiology schedule.

Description

Inclusion Criteria:

1. participants who have a clinical indication for a standard of care MRI exam that included assessment of the liver
2. participant is at least 18 years of age

Exclusion Criteria:

1. Participants unable to take part in the decision making process on whether to consent to the trial
2. Patients with previous chemoembolization or other focal liver therapies to the liver (* NOTE: for liver transplant patients, this criterion is only applicable to the transplanted liver)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Liver Fibrosis Measurement; Group1: Patients will undergo an Ultrasound to correlate fibrosis measurements obtained using standard-of-care MRI.	Diagnostic test: Ultrasound; Patients will undergo a standard liver US protocol for approximately 15 minutes.; Other Names: US elastography; US fat quantification
Patients with Liver Steatosis Measurement; Group 2: Patients will undergo an Ultrasound to correlate steatosis measurements obtained using standard-of-care MRI.	Diagnostic test: Ultrasound; Patients will undergo a standard liver US protocol for approximately 15 minutes.; Other Names: US elastography; US fat quantification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discriminatory value (AUC) of US in assessing liver stiffness	Discriminatory value (the ability of the test to diagnose disease from healthy) will be calculated using nonparametric receiver operating characteristic (ROC) curve analysis. Sensitivity (i.e. true positive rate: the ability of a test to correctly identify patients with the disease being investigated) is plotted on the y axis and 1-specificity (i.e. false positive rate: the test incorrectly identifies patients who do not have the disease being investigated as having the disease) will be plotted on the x-axis. Cutoff points of US liver stiffness values will be chosen to create the graph of sensitivity versus 1-Specificity, i.e. the ROC curve, and the area under the curve (AUC) is used to determine how well US discriminates patients with liver stiffness from patients without liver stiffness. The closer the AUC gets to 1, the more discriminatory the test. An AUC=0.5 is a test that is right 50% of the time, and is no better than flipping a coin.	an estimated time of 30 minutes
Discriminatory value (AUC) of US in assessing liver fat content	Discriminatory value (the ability of the test to diagnose disease from healthy) will be calculated using nonparametric receiver operating characteristic (ROC) curve analysis. Sensitivity (i.e. true positive rate: the ability of a test to correctly identify patients with the disease being investigated) is plotted on the y axis and 1-specificity (i.e. false positive rate: the test incorrectly identifies patients who do not have the disease being investigated as having the disease) will be plotted on the x-axis. Cutoff points of US liver fat content values will be chosen to create the graph of sensitivity versus 1-specificity, i.e. the ROC curve, and the area under the curve (AUC) is used to determine how well US discriminates patients with liver fat content from patients without liver fat content. The closer the AUC gets to 1, the more discriminatory the test. An AUC=0.5 is a test that is right 50% of the time, and is no better than flipping a coin.	an estimated average of 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
US Elastography Stiffness	MRI tissue stiffness is reported in shear modulus (S), while US uses Young's modulus (Y). Since Y = 2*(1+m)*S, where m is the Poisson's ratio for the material, and since that ratio is between 0.49 and 0.50 for tissue, the US measurements should be three times that of the MRI ones. In particular, treating the MRI measurements as the reference, theory predicts a linear relationship: Y = 0 + 3*S which can be tested with a linear regression model. The most straightforward means is by calculating the expected Young's modulus values for US from the MR measurements, and regressing them on the observed US measurements. Both US and MRI values are given below.	an estimated average of 30 minutes

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Aya Kamaya, MD, Stanford University; Principal Investigator: Andreas Loening, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (ACTUAL): November 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis
• Other Study ID Numbers: 38649

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No