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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to monitor primary sclerosing cholangitis (PSC), a liver disease that can cause serious issues like liver failure. Researchers are testing MR Elastography (MRE), a non-invasive imaging technique, to assess liver damage without a biopsy. They aim for MRE to assist doctors in determining the best treatments, potentially including liver transplants. Individuals with PSC or other chronic liver conditions who are already undergoing imaging tests might be suitable for this study. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future diagnostic methods.

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 prior data suggests that MR Elastography is safe for assessing liver fibrosis in PSC patients?

Studies have shown that both FibroScan and MR Elastography (MRE) are safe methods for assessing liver fibrosis. FibroScan uses a small device to measure liver stiffness. This non-invasive method does not involve surgery or needles. Research has shown it is well-tolerated by patients, with no serious side effects reported.

MR Elastography, another non-invasive method, uses MRI technology to capture images of the liver, allowing doctors to assess its stiffness. Studies indicate that MRE is highly accurate and safe, with no significant adverse events reported in patients undergoing this procedure.

Both FibroScan and MRE are widely used and considered safe ways to evaluate liver health without causing discomfort or harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using elastography techniques, like FibroScan and MR Elastography (MRE), for Primary Sclerosing Cholangitis (PSC) because they offer a non-invasive way to assess liver stiffness, which can be an indicator of fibrosis. Unlike traditional liver biopsies, which are invasive and carry certain risks, these imaging techniques provide valuable information without the need for tissue removal. This means patients can potentially benefit from more frequent monitoring with less discomfort and risk, allowing for more timely interventions. Additionally, these methods may offer more comprehensive data about liver health, which could lead to better-tailored treatments for individuals with PSC.

What evidence suggests that MR Elastography is effective for assessing primary sclerosing cholangitis?

This trial will compare MR Elastography (MRE) and FibroScan in assessing liver fibrosis in patients with primary sclerosing cholangitis (PSC). Research has shown that MRE is an excellent non-invasive method for detecting liver fibrosis, a major concern in PSC. Studies indicate that MRE can accurately identify cirrhosis and even predict long-term outcomes for PSC patients. FibroScan, another tool, effectively measures liver stiffness, which relates to the severity of liver damage in PSC. Both MRE and FibroScan provide important information about liver health without requiring a biopsy. These tools can help doctors monitor PSC more easily and select the best treatments. ^{2 6 7 8 9}

Who Is on the Research Team?

Kartik Jhaveri, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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

Pregnancy

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0301562920301411

Liver Elastography in Primary Sclerosing Cholangitis ...

Feasibility was good to excellent for all systems, with valid results for TE in 89.4%, for pSWE in 93.9% and for 2-D-SWE.GE in 71.2%. Median (range) LSM was 7.1 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24389304/

Baseline values and changes in liver stiffness measured by ...

Baseline values and changes in liver stiffness measured by transient elastography are associated with severity of fibrosis and outcomes of patients with primary ...

3.

gastrojournal.org

gastrojournal.org/article/S0016-5085(13)01844-1/fulltext

Baseline Values and Changes in Liver Stiffness Measured ...

Primary sclerosing cholangitis (PSC) is a chronic cholestatic disease that leads to extensive liver fibrosis and cirrhosis, which are associated with poor ...

4.

journal-of-hepatology.eu

journal-of-hepatology.eu/article/S0168-8278(22)00326-9/fulltext

EASL Clinical Practice Guidelines on sclerosing cholangitis

Small duct PSC has a more protracted and benign course compared to large duct PSC, resulting in longer survival with fewer patients progressing ...

5.

jhep-reports.eu

jhep-reports.eu/article/S2589-5559(23)00204-5/fulltext

Utility of ElastPQ point-shear wave elastography in the ...

Surrogate endpoints for clinical trials in primary sclerosing cholangitis: review and results from an International PSC Study Group consensus process.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5056739/

Validation of Transient Elastography and Comparison with ...

Patients with primary sclerosing cholangitis (PSC) develop progressive liver fibrosis and end-stage liver disease. Non-invasive and widely ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04480840

NCT04480840 | Phase 2a Evaluation of Safety, Tolerability ...

Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC). ClinicalTrials.gov ID ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S154235652300277X

Recent Advances in the Management of Primary ...

This review discusses relevant topics in the current understanding and management of patients with PSC through the lens of unmet therapeutic need.

9.

aasld.org

aasld.org/sites/default/files/2023-01/Hepatology%20-%202022%20-%20Bowlus%20-%20AASLD%20practice%20guidance%20on%20primary%20sclerosing%20cholangitis%20and%20cholangiocarcinoma.pdf

AASLD practice guidance on primary sclerosing ...

[201] Therefore, liver biopsy is not recommended for staging of fibrosis or prognostica- tion in PSC outside of the clinical trial setting. Liver stiffness.