Correlation of Ultrasound Based Measure… | Clinical Trial

Key information

Conditions

Liver Steatoses Digestive System Diseases Fatty Liver Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Stanford, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

Participants unable to take part in the decision making process on whether to consent to the trial
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)

Treatment and study plan

Ultrasound

Diagnostic Test

Patients will undergo a standard liver US protocol for approximately 15 minutes.

Other names: US elastography, US fat quantification

Primary outcomes

Discriminatory value (AUC) of US in assessing liver stiffness

Time frame: an estimated time of 30 minutes

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.
Discriminatory value (AUC) of US in assessing liver fat content

Time frame: an estimated average of 30 minutes

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.

Secondary outcomes

US Elastography Stiffness

Time frame: an estimated average of 30 minutes

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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Nov 17, 2017
Registry last updated: Apr 22, 2021

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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