Methods to Detect Liver Fibrosis

Status Terminated

Clinical Trial Summary

The goal of this study is to learn more about liver fibrosis and methods to detect it. We will evaluate and compare multiple MRI based measures of liver fibrosis in subjects with and without liver disease.

Clinical Trial Description

While liver biopsy is still considered the gold standard for diagnosing and assessing the presence and degree of liver fibrosis and inflammation, it has disadvantages including the potential for sampling error and risk of complications, including life-threatening bleeding. New imaging modalities such as MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer allow rapid, non-invasive evaluation of liver parenchymal characteristics and may be able to detect and quantify parenchymal fibrosis alleviating the need for biopsy. To date, the quantitative performance of these different techniques has not been extensively studied. This study is a single-center trial of non-invasive MR imaging techniques aimed at detecting and measuring liver fibrosis. Once optimized, these technologies may later be deployed in hypothesis driven research studies and/or routine clinical exams in the pediatric population here at CCHMC and/or as part of a multi-center study with specific IRB approval for that project.

To assess the relative performance of each technique, correlation across techniques, and reproducibility across the range of fibrosis, 32 subjects will be enrolled in this preliminary study sub-divided into 4 groups (Group 1: Healthy/ Normal controls; Group 2: F1/F2 fibrosis as determined by prior biopsy (low grade fibrosis group); Group 3: F3/F4 fibrosis as determined by prior biopsy (high grade fibrosis group), Group 4: Hepatic steatosis with fibrosis (NAFLD group)). 8 healthy subjects without known or suspected liver disease will be enrolled as normal controls. 8 subjects each with known fibrosis based on liver biopsy within the last 6 months will be enrolled in Group 2 and Group 3 (total = 16). 8 subjects with known hepatic steatosis and liver fibrosis based on liver biopsy within the last 6 months will be enrolled in Group 4. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03027700
Study type	Interventional
Source	Children's Hospital Medical Center, Cincinnati
Contact
Status	Terminated
Phase	N/A
Start date	January 26, 2017
Completion date	December 30, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05480696` - Soluble Fibre Supplementation in NAFLD	Phase 1
Completed	`NCT05124847` - TREating Pediatric Obesity	N/A
Recruiting	`NCT05499585` - Treating Pediatric NAFLD With Nutrition	N/A
Completed	`NCT03717935` - Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS	N/A
Active, not recruiting	`NCT02493153` - Hepatic Steatosis After Cholecystectomy	N/A
Active, not recruiting	`NCT05654051` - The SLIM LIVER Study	Phase 2
Completed	`NCT03334214` - Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes	Phase 2
Recruiting	`NCT05599945` - First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases	Phase 1
Enrolling by invitation	`NCT02816814` - Lacto-ovo-vegetarian Diet Riched in Omega-3 Fatty Acids in Menopausal Women	N/A
Active, not recruiting	`NCT03587727` - Hepatic Mitochondrial Function in Youth
Not yet recruiting	`NCT06394206` - Benefit of a Hospital Intervention in Patients With Hepatic Steatosis	N/A
Not yet recruiting	`NCT06363617` - Implementation of the Fatty Liver Index in Primary Care	N/A
Not yet recruiting	`NCT05935826` - Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)	N/A
Recruiting	`NCT03142698` - Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis	N/A
Completed	`NCT00480922` - Effects of a Low Glycemic Load Diet on Fatty Liver in Children	N/A
Not yet recruiting	`NCT05871749` - Effects of Hepatic Fibrosis on Hepatic Steatosis Using the Ultrasound Attenuation Imaging in Chronic Hepatitis B
Recruiting	`NCT05897073` - Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity	N/A
Completed	`NCT03961516` - Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis
Completed	`NCT04180631` - Quantitative US for Hepatic Steatosis	N/A
Terminated	`NCT00845845` - Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.