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

NCT03342703 | Completed FDA Device

• 1 other identifier: 38649
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Liver Steatoses; Liver Cirrhosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• US Elastography Stiffness

  an estimated average of 30 minutes

Study Arms (2)

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 with Liver Steatosis Measurement

Group 2: Patients will undergo an Ultrasound to correlate steatosis measurements obtained using standard-of-care MRI.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

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

Also known as: US elastography, US fat quantification

Patients with Liver Fibrosis Measurement; Patients with Liver Steatosis Measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford University Hospital

Stanford, California, 94305, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Fatty Liver; Liver Cirrhosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Aya Kamaya, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Andreas Loening, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 17, 2017
• Study Start: August 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)