Trial Summary
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.
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.
12345Is 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.
15678How 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.
12459Eligibility 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 am 18 years old or older.
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)
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Direct Comparison of US and MR Elastography for Staging Liver Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. [2022]As alternatives to the expensive liver biopsy for assessing liver fibrosis stage in patients with nonalcoholic fatty liver disease (NAFLD), we directly compared the diagnostic abilities of magnetic resonance elastography (MRE), vibration-controlled transient elastography (VCTE), and two-dimensional shear wave elastography (2D-SWE).
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]Magnetic resonance imaging (MRI) techniques and ultrasound-based transient elastography (TE) can be used in noninvasive diagnosis of fibrosis and steatosis in patients with nonalcoholic fatty liver disease (NAFLD). We performed a prospective study to compare the performance of magnetic resonance elastography (MRE) vs TE for diagnosis of fibrosis, and MRI-based proton density fat fraction (MRI-PDFF) analysis vs TE-based controlled attenuation parameter (CAP) for diagnosis of steatosis in patients undergoing biopsy to assess NAFLD.
Early detection of nonalcoholic steatohepatitis in patients with nonalcoholic fatty liver disease by using MR elastography. [2022]To investigate the diagnostic accuracy (area under the receiver operating characteristic curve [AUROC]) of magnetic resonance (MR) elastography for the early detection of nonalcoholic steatohepatitis (NASH) among patients with nonalcoholic fatty liver disease (NAFLD).
Editorial: Magnetic Resonance Elastography and Non-Alcoholic Fatty Liver Disease: Time for an Upgrade? [2018]Elastography techniques, such as two-dimensional magnetic resonance elastography (2D-MRE) are increasingly used for the non-invasive assessment of liver fibrosis in patients with nonalchoholic fatty liver disease (NAFLD). Loomba et al. demonstrate that 3D-MRE (shear wave frequency 40 Hz) had even greater diagnostic accuracy than the commercially available 2D-MRE (shear wave frequency 60 Hz) in diagnosing advanced fibrosis (area under the receiver operator curve, AUROC 0.981 vs. 0.921, P
MRE in NAFLD: Promising but Further Validation is Required. [2021]MR elastography is a novel method for non-invasive fibrosis assessment, not yet sufficiently validated. In a recent study in 104 patients Park, Gastroenterology 2017; 152: 598-602), MRE was compared to transient elastography for the diagnosis of fibrosis is nonalcoholic fatty liver disease. The current viewpoint critically appraises this study.
Liver stiffness accuracy by magnetic resonance elastography in histologically proven non-alcoholic fatty liver disease patients: a Spanish cohort. [2023]to evaluate the performance of magnetic resonance elastography (MRE) to stage liver fibrosis in patients with histologically confirmed nonalcoholic fatty liver disease (NAFLD) and to assess the impact of potential confounding factors in MRE diagnostic accuracy. The secondary objective was to compare MRE with other non-invasive methods for staging fibrosis such as transient elastography (TE) and non-invasive scores (APRI and FIB-4).
Association Between Obesity and Discordance in Fibrosis Stage Determination by Magnetic Resonance vs Transient Elastography in Patients With Nonalcoholic Liver Disease. [2020]Magnetic resonance elastography (MRE) and transient elastography (TE) are noninvasive techniques used to detect liver fibrosis in nonalcoholic fatty liver disease. MRE detects fibrosis more accurately than TE, but MRE is more expensive, and the concordance between MRE and TE have not been optimally assessed in obese patients. It is important to determine under which conditions TE and MRE produce the same readings, so that some patients can simply undergo TE evaluation to detect fibrosis. We aimed to assess the association between body mass index (BMI) and discordancy between MRE and TE findings, using liver biopsy as the reference, and validated our findings in a separate cohort.
Diagnostic Performance of MR Elastography and Vibration-controlled Transient Elastography in the Detection of Hepatic Fibrosis in Patients with Severe to Morbid Obesity. [2022]Purpose To evaluate the diagnostic performance and examination success rate of magnetic resonance (MR) elastography and vibration-controlled transient elastography (VCTE) in the detection of hepatic fibrosis in patients with severe to morbid obesity. Materials and Methods This prospective and HIPAA-compliant study was approved by the institutional review board. A total of 111 patients (71 women, 40 men) participated. Written informed consent was obtained from all patients. Patients underwent MR elastography with two readers and VCTE with three observers to acquire liver stiffness measurements for liver fibrosis assessment. The results were compared with those from liver biopsy. Each pathology specimen was evaluated by two hepatopathologists according to the METAVIR scoring system or Brunt classification when appropriate. All imaging observers were blinded to the biopsy results, and all hepatopathologists were blinded to the imaging results. Examination success rate, interobserver agreement, and diagnostic accuracy for fibrosis detection were assessed. Results In this obese patient population (mean body mass index = 40.3 kg/m2; 95% confidence interval [CI]: 38.7 kg/m2, 41.8 kg/m2]), the examination success rate was 95.8% (92 of 96 patients) for MR elastography and 81.3% (78 of 96 patients) or 88.5% (85 of 96 patients) for VCTE. Interobserver agreement was higher with MR elastography than with biopsy (intraclass correlation coefficient, 0.95 vs 0.89). In patients with successful MR elastography and VCTE examinations (excluding unreliable VCTE examinations), both MR elastography and VCTE had excellent diagnostic accuracy in the detection of clinically significant hepatic fibrosis (stage F2-F4) (mean area under the curve: 0.93 [95% CI: 0.85, 0.97] vs 0.91 [95% CI: 0.83, 0.96]; P = .551). Conclusion In this obese patient population, both MR elastography and VCTE had excellent diagnostic performance for assessing hepatic fibrosis; MR elastography was more technically reliable than VCTE and had a higher interobserver agreement than liver biopsy. © RSNA, 2016 Online supplemental material is available for this article. An earlier incorrect version of this article appeared online. This article was corrected on January 25, 2017.
Diagnostic methods of fatty liver diseases. [2022]Fatty liver diseases represent the most common chronic liver diseases today. Therefore, the diagnostics of fatty liver is of great importance. Sonography is the most used imaging method in daily clinical practice for its availability and good diagnostic performance. But there are limitations in lower sensitivity in mild steatosis and in subjects with more severe obesity. Sonographic findings of fatty liver include higher echogenity of liver parenchyma and attenuation of ultrasound waves in deeper parts of the liver. Furthermore, there are some other advanced methods for semiquantitative and quantitative assessment of the amount of the liver fat. Many of them are based on acoustic signal attenuation assessment. The most broadly used is a CAP (controlled attenuation parameter) feature of FibroScan, which can assess fatty liver without classic ultrasound examination. Thera are also special MR based techniques - MR spectroscopy and PDFF (protein density fat fraction) which allow liver fat quantification with high precision and can be used as a reference standard.