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

NCT ID: NCT03342703

Last Updated: 2021-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Steatoses Liver Cirrhosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Liver Fibrosis Measurement

Group1: Patients will undergo an Ultrasound to correlate fibrosis measurements obtained using standard-of-care MRI.

Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Patients with Liver Steatosis Measurement

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

Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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US elastography US fat quantification

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Aya Kamaya

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aya Kamaya, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Andreas Loening, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University Hospital

Stanford, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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38649

Identifier Type: -

Identifier Source: org_study_id

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