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

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ClinicalTrials.gov Identifier: NCT03342703
Recruitment Status : Unknown
Verified September 2018 by Aya Kamaya, Stanford University.
Recruitment status was:  Recruiting
First Posted : November 17, 2017
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Aya Kamaya, Stanford University

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

Condition or disease Intervention/treatment
Liver Steatoses Liver Cirrhosis 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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of Ultrasound Based Measurements of Liver Stiffness and Steatosis With MRI
Actual Study Start Date : November 4, 2016
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020


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




Primary Outcome Measures :
  1. 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.


  2. 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 Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342703


Contacts
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Contact: Andrea Otte anotte@stanford.edu

Locations
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United States, California
Stanford University Hospital Recruiting
Stanford, California, United States, 94305
Contact: Andrea Otte       anotte@stanford.edu   
Sub-Investigator: Andreas Loening, MD         
Principal Investigator: Aya Kamaya, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Andreas Loening, MD    650-725-4936    loening@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Aya Kamaya, MD Stanford University
Principal Investigator: Andreas Loening, MD Stanford University
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Responsible Party: Aya Kamaya, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03342703    
Other Study ID Numbers: 38649
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Liver Cirrhosis
Fatty Liver
Liver Diseases
Digestive System Diseases