Elastography for Primary Sclerosing Cholangitis

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Pacemaker, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

82 Participants Needed

Trial Summary

What is the purpose of this trial?

Primary sclerosing cholangitis (PSC) is a chronic liver disease that can lead to liver cirrhosis, liver failure and liver cancer. Assessment of disease status is important to determine optimal treatment but the diagnosis of PSC is challenging. There is a dire need of an accurate non-invasive tool for longitudinal assessment of PSC. MR Elastography (MRE) has been recently proven to estimate liver fibrosis noninvasively and accurately. Estimation of liver fibrosis by MRE along with imaging derived morphological information (MRCP) will be utilized in this study comprehensively to provide a surrogate non-invasive imaging biomarker for monitoring disease status in PSC. Successful outcomes will provide an opportunity for optimal treatment triage including liver transplantation via accurate and non-invasive estimation of true disease status in PSC.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment FibroScan and MR Elastography (MRE) for primary sclerosing cholangitis?

Research shows that measuring liver stiffness using MR Elastography (MRE) and FibroScan (a type of transient elastography) can help predict disease severity and outcomes in patients with primary sclerosing cholangitis by assessing liver fibrosis and related complications. ^{1 2 3 4 5}

Is elastography safe for humans?

Elastography, including MR Elastography (MRE) and FibroScan, is generally considered safe for humans as it is a non-invasive imaging technique used to assess liver stiffness and fibrosis without the need for surgery or radiation. ^{1 2 6 7 8}

How does elastography differ from other treatments for primary sclerosing cholangitis?

Elastography is unique because it is a non-invasive imaging technique that measures liver stiffness to assess fibrosis, which is crucial for predicting outcomes in primary sclerosing cholangitis. Unlike other treatments that may focus on managing symptoms or complications, elastography provides valuable diagnostic and prognostic information without the need for invasive procedures. ^{1 2 3 4 6}

Research Team

Kartik Jhaveri, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for patients with known Primary Sclerosing Cholangitis (PSC) and a control group of patients with other chronic liver diseases who've had a recent liver biopsy. It's not suitable for individuals without these conditions or those who haven't been under imaging surveillance recently.

Inclusion Criteria

Patients with known PSC

I have a chronic liver disease, not PSC, with a recent liver biopsy and am under imaging checks.

Exclusion Criteria

I don't have a pacemaker or any metal implants that prevent MRI scans.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo MR Elastography, FibroScan, and standard of care biopsy to assess liver fibrosis and disease status

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in liver fibrosis and disease status using non-invasive imaging techniques

3 months

1 visit (in-person)

Treatment Details

Interventions

• FibroScan
• MR Elastography (MRE)

Trial Overview The study tests MR Elastography (MRE) and FibroScan as non-invasive tools to assess liver fibrosis in PSC. The goal is to use these methods, along with MRI, to monitor disease status accurately without needing invasive procedures like biopsies.

Participant Groups

Group I: PSC Patients Experimental Treatment 1 Intervention

MR Elastography, Fibroscan and standard of care biopsy

Group II: Non-PSC Patients Active Control 1 Intervention

MR Elastography, Fibroscan and standard of care biopsy

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

Magnetic resonance elastography (MRE) is an effective and non-invasive method for detecting and staging liver fibrosis in patients with nonalcoholic fatty liver disease (NAFLD), showing a high accuracy with an area under the ROC curve (AUROC) of 0.90 for advanced fibrosis (≥ F3).

MRE outperforms transient elastography (TE) and non-invasive scores (APRI and FIB-4) in accuracy, and while factors like liver inflammation can affect MRE results, only gamma-glutamyl transferase (GGT) was significantly associated with overestimation of liver stiffness in the analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver stiffness accuracy by magnetic resonance elastography in histologically proven non-alcoholic fatty liver disease patients: a Spanish cohort. Lara Romero, C., Liang, JX., Fernández Lizaranzazu, I., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Risk stratification in primary sclerosing cholangitis: comparison of biliary stricture severity on MRCP versus liver stiffness by MR elastography and vibration-controlled transient elastography. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Liver Stiffness Measured by Either Magnetic Resonance or Transient Elastography Is Associated With Liver Fibrosis and Is an Independent Predictor of Outcomes Among Patients With Primary Biliary Cholangitis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

MR elastography in primary sclerosing cholangitis: correlating liver stiffness with bile duct strictures and parenchymal changes. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of quantitative MRCP (MRCP+) for risk stratification of primary sclerosing cholangitis: comparison with morphological MRCP, MR elastography, and biochemical risk scores. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of liver stiffness measurement with MRE and liver and spleen volumetry for prediction of disease severity and hepatic decompensation in patients with primary sclerosing cholangitis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

MR elastography in primary sclerosing cholangitis: a pictorial review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of interobserver agreement of magnetic resonance elastography with histopathological staging of liver fibrosis. [2014]

8. Spain pubmed.ncbi.nlm.nih.gov

Liver stiffness accuracy by magnetic resonance elastography in histologically proven non-alcoholic fatty liver disease patients: a Spanish cohort. [2023]