800 Participants Needed

Diagnostic Techniques for Fatty Liver Disease

SG
JL
Overseen ByJessica L Olson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for fatty liver disease?

Research shows that Magnetic Resonance Elastography (MRE) is a promising non-invasive method for assessing liver fibrosis in patients with nonalcoholic fatty liver disease (NAFLD), with studies indicating it has high diagnostic accuracy compared to other techniques.12345

Is Magnetic Resonance Elastography (MRE) safe for diagnosing liver conditions?

Magnetic Resonance Elastography (MRE) is a non-invasive technique used to assess liver fibrosis and is generally considered safe for humans. It is more reliable and accurate than some other methods, like transient elastography, especially in patients with obesity.15678

How is the treatment for fatty liver disease using liver biopsy and magnetic resonance elastography different from other treatments?

This treatment is unique because it uses magnetic resonance elastography (MRE), a non-invasive imaging technique, to assess liver fibrosis and fat content with high precision, unlike traditional liver biopsies that are invasive and can be expensive. MRE provides a safer and more comfortable option for patients, offering detailed insights into liver health without the need for surgical procedures.12459

What is the purpose of this trial?

Researchers are assessing the prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) in the population and assembling a well-characterized cohort of adults with NAFLD and NASH to validate models of NAFLD diagnosis and determine long-term outcomes.

Research Team

AM

ALINA M ALLEN, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This study is for adults over 18 living in Olmsted County without a previous NAFLD diagnosis. It's not for those with MRI-incompatible devices, severe claustrophobia, heavy alcohol users (over 20g/week for women and 30g/week for men), or pregnant individuals.

Inclusion Criteria

I have never been diagnosed with fatty liver disease.
Olmsted County residents at the time of search

Exclusion Criteria

Currently pregnant
Alcohol in excess (more than 20 gm per week in women and 30 gm per week in men)
Have contraindications to MRI (MRI incompatible implanted devices, severe claustrophobia)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants undergo Magnetic Resonance Imaging (MRE), blood tests, and possible biopsy to assess NAFLD and NASH

5 years

Follow-up

Participants are monitored for long-term health outcomes including the development of NAFLD, NASH, and related complications

5 years

Treatment Details

Interventions

  • Liver biopsy
  • Magnetic Resonance Elastography
Trial Overview The TONES study is looking at how common NAFLD and NASH are among people. It uses Magnetic Resonance Elastography, blood tests, Fibro Scan, and liver biopsies to build a detailed picture of these liver conditions.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Subjects at risk for NAFLDExperimental Treatment4 Interventions
Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

Magnetic resonance elastography (MRE) showed the highest diagnostic accuracy for detecting stage 4 liver fibrosis in patients with nonalcoholic fatty liver disease (NAFLD) among the three tested methods, which included vibration-controlled transient elastography (VCTE) and two-dimensional shear wave elastography (2D-SWE).
MRE also demonstrated superior intra- and inter-observer reproducibility compared to VCTE and 2D-SWE, indicating that it provides more consistent results when assessing liver fibrosis stage.
Direct Comparison of US and MR Elastography for Staging Liver Fibrosis in Patients With Nonalcoholic Fatty Liver Disease.Imajo, K., Honda, Y., Kobayashi, T., et al.[2022]
In a study of 104 adults with nonalcoholic fatty liver disease (NAFLD), magnetic resonance elastography (MRE) was found to be significantly more accurate than transient elastography (TE) for diagnosing liver fibrosis, with an area under the receiver operating characteristic curve (AUROC) of 0.82 compared to TE's 0.67.
MRI-based proton density fat fraction (MRI-PDFF) analysis demonstrated exceptional accuracy in detecting steatosis, achieving an AUROC of 0.99, which was superior to the controlled attenuation parameter (CAP) method, which had an AUROC of 0.85.
Magnetic Resonance Elastography vs Transient Elastography in Detection of Fibrosis and Noninvasive Measurement of Steatosis in Patients With Biopsy-Proven Nonalcoholic Fatty Liver Disease.Park, CC., Nguyen, P., Hernandez, C., et al.[2022]
Magnetic resonance elastography (MR elastography) demonstrated high diagnostic accuracy (AUROC = 0.93) for detecting nonalcoholic steatohepatitis (NASH) in patients with nonalcoholic fatty liver disease (NAFLD), with a sensitivity of 94% and specificity of 73%.
The study found that hepatic stiffness measurements can differentiate between patients with simple steatosis, those with inflammation but no fibrosis, and those with fibrosis, indicating that MR elastography can identify NASH even before fibrosis develops.
Early detection of nonalcoholic steatohepatitis in patients with nonalcoholic fatty liver disease by using MR elastography.Chen, J., Talwalkar, JA., Yin, M., et al.[2022]

References

Direct Comparison of US and MR Elastography for Staging Liver Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. [2022]
Magnetic Resonance Elastography vs Transient Elastography in Detection of Fibrosis and Noninvasive Measurement of Steatosis in Patients With Biopsy-Proven Nonalcoholic Fatty Liver Disease. [2022]
Early detection of nonalcoholic steatohepatitis in patients with nonalcoholic fatty liver disease by using MR elastography. [2022]
Editorial: Magnetic Resonance Elastography and Non-Alcoholic Fatty Liver Disease: Time for an Upgrade? [2018]
MRE in NAFLD: Promising but Further Validation is Required. [2021]
Liver stiffness accuracy by magnetic resonance elastography in histologically proven non-alcoholic fatty liver disease patients: a Spanish cohort. [2023]
Association Between Obesity and Discordance in Fibrosis Stage Determination by Magnetic Resonance vs Transient Elastography in Patients With Nonalcoholic Liver Disease. [2020]
Diagnostic Performance of MR Elastography and Vibration-controlled Transient Elastography in the Detection of Hepatic Fibrosis in Patients with Severe to Morbid Obesity. [2022]
9.Czech Republicpubmed.ncbi.nlm.nih.gov
Diagnostic methods of fatty liver diseases. [2022]
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