Clinical trial NCT03342703: Correlation of Ultrasound Based Measurements of Liver Stiffness and Steatosis With MRI
Official title: Correlation of Ultrasound Based Measurements of Liver Stiffness and Steatosis With MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Steatoses
Liver Cirrhosis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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)

Primary outcomes:
measure: Discriminatory value (AUC) of US in assessing liver stiffness
timeFrame: an estimated time of 30 minutes
measure: Discriminatory value (AUC) of US in assessing liver fat content
timeFrame: an estimated average of 30 minutes
Secondary outcomes:
measure: US Elastography Stiffness
timeFrame: an estimated average of 30 minutes
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Aya Kamaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Andreas Loening, MD
role: PRINCIPAL_INVESTIGATOR
References: