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30 active trials for Liver Fibrosis

Rapid Breath-hold Quantitative Macromolecular Proton Fraction Imaging for Liver Fibrosis

Chronic liver disease is a major health problem worldwide. Liver fibrosis is a key feature in most chronic liver diseases. When identified early, liver fibrosis may be reversible. Currently, liver biopsy is the gold standard for the diagnosis of liver fibrosis. Liver biopsy; however, is invasive. Non-invasive diagnostic tools are increasingly used in clinical practice. However, the existing noninvasive methods still have significant limitations to detect early-stage liver fibrosis. Liver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver. The macromolecular proton fraction (MPF) is an MRI parameter which characterizes the magnetization transfer (MT) effect in tissues. Quantitative MPF imaging is non-invasive and can be used to measure collagen deposition in the liver due to the strong MT effect of collagen. It has been reported MPF quantification can be used for diagnosis of early-stage liver fibrosis. However, the existing approaches require B1, B0, and T1 map in addition to the imaging data for MPF quantification, which makes it challenging to adopt them for routine clinical use. The investigators propose a fast and robust MPF quantification approach. In contrast to the existing methods which rely on saturation radiofrequency pulses for MPF quantification, our approach is based on spin-lock radiofrequency pulses which have minimum Rabi oscillations. The whole imaging data can be acquired within a breath-hold less than 8 seconds. Our approach only needs a B1 map in addition to the imaging data for MPF quantification. The preliminary clinical studies on 3.0T MRI show the measurement using our approach is specific to collagen content and can be used to detect early-stage liver fibrosis. To further confirm the clinical value of the proposed approach, the investigators will investigate the relationship of the collagen content measured using the proposed non-invasive imaging approach and those measured based on morphometry analysis of histology, and determine the diagnostic value of the proposed method for detection of early stage liver fibrosis in a large cohort. The investigators will also perform comparative studies of the proposed method and the state-of-the-art quantitative MPF imaging technique. This project will provide a diagnostic technology for early detection of liver fibrosis. The proposed MRI technology also has potential to be used for other clinical purposes.

Start: March 2021
Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients

Non-Alcoholic Fatty Liver is a common clinical and histological condition associated with metabolic syndrome in patients with and without excess body weight. It represents the most common cause of liver disease in the western world and it is characterized by an excess accumulation of fatty vacuole within hepatocytes. Patients with non-alcoholic fatty liver disease (NAFLD) can progress to non-alcoholic steatohepatitis (NASH), and then into cirrhosis and its complications. The prevalence of hepatic steatosis goes from 16 to 31% in the general population, from 50 to 80% in the obese population and up to 96% in morbidly obese patients. As the majority of obese individuals have NAFLD, non-invasive and widely applicable screening tools for the assessment of liver fibrosis and steatosis are needed. The detection in early stages is the main predictive factor of the long-term outcome. Liver biopsy has traditionally been the gold standard for the assessment of patients with NAFLD, although the well-known limitations. Among the non-invasive tools available in the market, the FibroScan® (Echosens™, Paris, France) has been shown to be a useful tool for diagnosing fibrosis and steatosis in patients with suspected NAFLD. The FibroScan® is an ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to liver stiffness measurement (LSM) and the controlled attenuation parameter (CAP). Several clinical studies have shown the benefit of measuring hepatic stiffness with the FibroScan® in overweight/moderately obese persons. The ability to identify significant fibrosis and cirrhosis has been demonstrated in normal and overweight patients affected with chronic hepatitis B and C, biliary diseases, alcohol related liver disease and NAFLD. However, subcutaneous fat attenuates the transmission of shear waves into the liver and the ultrasonic signals used to measure their speed of propagation. When scanning morbidly obese patients (BMI?35 kg/m²) with the XL+ probe, unreliable results occur mainly due to obesity. Therefore, the XL probe has been enabled to expand the applicability of the FibroScan® but, the realization of the XL+ examination is still very difficult in the case of morbidly obese patients. This is why to reduce this failure rate, Echosens has worked on developing the XXL probe specifically for measuring the LSM in morbidly obese patients.

Start: September 2019
HBsAg Seroclearance in Adults With HBV Related Liver Fibrosis After Receiving Combined Therapy of Peg-IFN and Tenofovir.

Liver fibrosis caused by hepatitis B virus (HBV) infection is easy to progress to liver cirrhosis and liver cancer, with great harm and poor therapeutic effect. Nucleos(t)ide analogues (NAs) are the most commonly anti-HBV drugs currently . Long-term use of NAs can inhibit HBV DNA and achieve the purpose of reducing poor prognosis. However, adverse prognosis, such as liver cirrhosis and liver cancer, cannot be completely eliminated even under the status of virologic inhibition under THE action of NAs. Current studies have shown that the lower the HBV surface antigen (HBsAg) is, the better the long-term prognosis is. As another anti-HBV drug, pegylated-interferon-? (peg-IFN-?) has the immune regulation effect that NAs do not have, which can bring irreplaceable effects in HBsAg reduction and liver fibrosis reversal. Therefore, the combined therapy of NAs and peg-IFN-? is a hot issue in the field of liver diseases over the world, but the research and application of the combined therapy in patients with liver fibrosis are very few. The preliminary results of our previous research showed that the combined therapy of peg-IFN-? and NAs in patients with HBV related fibrosis were safe, and had a significant effect on HBsAg decline. On this basis, this study intends to carry out a multicentre, randomized controlled study, comparing the safety and efficacy between combined therapy (peg-IFN-? plus tenofovir) and tenofovir monotherapy in patients with liver fibrosis, especially focusing on HBsAg's decline and clearance, and the improvement of liver fibrosis degree, in order to find a better therapy, and to guide the clinical decision making.

Start: November 2020
MTX-related Liver Toxicity in Psoriasis Patients, Using Ultrasound-based Techniques as a Diagnostic Tool

Methotrexate is one of the commonly used conventional systemic treatment for moderate to severe psoriasis as well as psoriatic arthritis. It is also used as co-therapy with TNF-antagonists to improve efficacy and reduce neutralizing drug antibodies formation. Apart from the bone marrow suppression, which can largely be avoided with careful dosing, monitoring and avoidance of certain drug interaction, hepatotoxicity is one of the major side-effects. The prevalence of significant liver fibrosis in patients taking methotrexate is estimated to be 5% and cirrhosis 1-2%. The British Association of Dermatologist's guideline (2016) discussed a few non-invasive tests such as the amino-terminal peptide of procollagen III (PIIINP), Fibrotest and transient elastography. While PIIINP was recommended to be used in baseline and serial assessment, liver stiffness measurement by transient elastography is not yet widely used owing to lack of high-quality data. Transient elastography (TE) has been shown to correlate well with liver fibrosis and has been widely adopted as a non-invasive method to assess liver fibrosis in various chronic liver disease. Two-dimensional shear wave elastrography (2D SWE) is a novel ultrasound technique that combines shear wave elastography with traditional ultrasound imaging. Liver stiffness measurement can be performed under the guidance of high rate B-mode image, allowing real-time visualization of liver parenchyma and avoidance of non-target structures such as vessels or focal liver lesions. In view of the demand of a safer and reliable non-invasive test to detect advanced liver fibrosis in psoriasis patients receiving methotrexate, we propose to recruit at-risk patients for a paired TE and 2D SWE assessment and liver biopsy.

Start: June 2019