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Liver Fibrosis clinical trials

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NCT ID: NCT04533828 Recruiting - Liver Fibrosis Clinical Trials

68Ga-FAPI PET/CT in Liver Fibrosis Patients

GFAPILF
Start date: September 1, 2020
Phase: Early Phase 1
Study type: Interventional

To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis and prognosis in liver fibrosis disease.

NCT ID: NCT04429100 Recruiting - Liver Fibrosis Clinical Trials

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

Start date: March 1, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT04389593 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Comparative and Additive Diagnostic Performance of Magnetic Resonance Elastography (MRE) and Corrected-T1 (cT1) for Fibrosis and Inflammation in Nonalcoholic Steatohepatitis (NASH) Using Histology as Reference

Start date: May 21, 2019
Phase:
Study type: Observational

This pilot study will evaluate conventional and investigational MR imaging and spectroscopic sequences and collect data to help plan more definitive future studies.

NCT ID: NCT04277819 Completed - Cystic Fibrosis Clinical Trials

The Use of Novel Diagnostic Tools to Increase Detection of Early Fibrosis in Cystic Fibrosis Related Liver Disease to Improve Clinical Management

Start date: February 15, 2019
Phase:
Study type: Observational [Patient Registry]

Cystic Fibrosis (CF) is a genetic condition which affects 1 in 2500 newborn infants and is the commonest genetic condition in the UK. 1 in 25 of the white population carry the mutation. The genetic defect prevents the movement of fluids from cells, leading to thickened secretions and injury. With improvements in treatments from the commonest organ affected, the lungs, patients born with CF now can expect to live into their 40s with more than 60% living past 16. Though better, more can be done. As treatments from lung complications have improved, the management of liver disease (second commonest organ involved) remains unchanged for a considerable time. Treatment options are limited with liver transplant the only curative option. Though potentially life-saving, it has risks and an organ shortage means alternative treatment options are desperately needed. Identifying those with or at risk of Cystic Fibrosis related liver disease is difficult due to inadequate diagnostic tools. Routine blood tests are unreliable; therefore specific blood tests to identify scarring of the liver (biomarkers) are urgently needed. Ultrasound scan, the recommended diagnostic investigation, is only accurate in identifying the late stages of liver disease. For new therapies to be most effective we need to be able to identify patients at a much earlier stage. This study will use multi-modality testing, including imaging techniques such as FibroScan, MRI scan and blood tests (biomarkers), to diagnose those with liver scarring and use this to better categorise disease.

NCT ID: NCT04168619 Recruiting - Psoriasis Clinical Trials

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

Start date: June 10, 2019
Phase:
Study type: Observational

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.

NCT ID: NCT04155398 Recruiting - Liver Fibroses Clinical Trials

EUS Elastography for Predicting Cirrhotic-related Complications

Start date: November 4, 2019
Phase:
Study type: Observational

Evaluation of the tissue stiffness as a surrogate marker of degree of liver cirrhosis has gained popularity in recent decades. Current guidelines also advocate the use of Fibroscan® machine (EchoSens, Paris, France) to detect any advanced liver fibrosis as represented by high liver stiffness, for prediction of varices development. Apart from liver stiffness, studies have shown that spleen stiffness (SS) has been proven another useful parameter to severity of underlying portal hypertension and liver cirrhosis. However, spleen stiffness measurement by Fibroscan® is highly limited by the thickness of subcutaneous soft tissue or abdominal wall tissue, especially in obese subjects. It carries certain technical difficulty as well due to its deep-seated anatomical position. Recently, the technique of endoscopic ultrasound elastography (EUS-E) has been described. It can overcome the limitations of Fibroscan by making measurements of liver and spleen stiffness through the gastric wall, which has a shorter distance than the abdominal wall. It also allows concomitant upper GI tract luminal examination, incorporating both esophagogastroduodenoscopy and elastography measurements into one procedure at the same time. This research study aims to prospectively study the utility of EUS-E in patients with chronic liver diseases, both in terms of diagnostic and prognostic indications for future cirrhotic-related complications.

NCT ID: NCT04146636 Completed - NAFLD Clinical Trials

Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)

IMPROVE
Start date: December 9, 2019
Phase: N/A
Study type: Interventional

The main objective is to determine the performance of the simple eLIFT blood test for advanced liver fibrosis screening in NAFLD and/or alcoholic patients in primary care.

NCT ID: NCT04115046 Completed - Liver Fibroses Clinical Trials

The EUS ShearWave Elastography Liver Fibrosis Study

Start date: July 14, 2020
Phase:
Study type: Observational

The study objective is to demonstrate the clinical performance of ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS) when compared to FibroScan for evaluation of liver fibrosis.

NCT ID: NCT04099407 Completed - Liver Fibrosis Clinical Trials

Pirfenidone and Advanced Liver Fibrosis.

PROMETEO
Start date: August 1, 2019
Phase: Phase 2
Study type: Interventional

Pirfenidone (PFD), an oral antifibrotic drug with anti-inflammatory and anti-oxidant properties, has been granted marketing authorization by the European Medicine Agency and FDA, for the treatment of idiopathic pulmonary fibrosis (IPF). However, few studies have focused on its clinical utilization in patients with advanced hepatic fibrosis. Therefore, Investigators aim to evaluate a prolonged-release PFD formulation (PR-PFD) plus standard of care management on disease progression in patients with advanced liver fibrosis (ALF). Methods: Patients with diverse chronic liver disease etiology (alcohol-related, hepatitis B or C, autoimmune or fatty liver disease) will be screened with two non invasive liver fibrosis methods (Fibroscan®) and Fibro Test®) and those with ALF (F3 or F4) will be treated for at least 12 months with PR-PFD. Antifibrotic effects Will be assessed at 6 and 12 months; variations greater than 30% in estimated fibrosis scores or 1 point on the METAVIR scale will be considered clinically significant. PFD plasma levels, serum endothelin-1, IL6, TNFα and TGFβ1, Quality of life and fatigue scales will be evaluated. Parametric and non parametric statistics will be utilized and p values lower tan 5% will be considered clinically significant.

NCT ID: NCT04036357 Recruiting - Clinical trials for Cardiovascular Diseases

Liver Damage and Cardiometabolic Disorders in NAFLD

PLINIO
Start date: November 2011
Phase:
Study type: Observational

Liver fibrosis is the most important prognostic factor in patients with non-alcoholic factor disease. Clinical and biological condition, as diabetes or mutation for PNPLA3, are well known factors associated with liver fibrosis onset and progression. However, little is known about biochemical factors predicting liver fibrosis evolution in large NAFLD populations.