Quantitative Magnetic Resonance Imaging in Biliary Disease: Health Economics Study

NCT04015310 | Withdrawn DMC FDA Device

• 1 other identifier: EC-156
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a health economic study on using quantitative magnetic resonance imaging in biliary disease. It is an observational study aiming to recruit 40 patients with Primary Sclerosing Cholangitis (PSC) in 12 months. The aim of the study is to assess the effect of result of enhanced Magnetic Resonance Cholangiopancreatography (MRCP+) on the physicians' diagnosis and/or plans for patients with suspected or confirmed PSC, compared with usual standard of care. This study also aims to identify the cost-effectiveness of adding MRCP+ to the standard care pathway.

Conditions

Primary Sclerosing Cholangitis; PSC

Keywords

MRCP; MRCP+; PSC; Health economic

Outcome Measures

Primary Outcomes (1)

• quantitative measurements using Enhance MRCP (MRCP+) and Physicians' decision making

  To assess the effect of quantitative data from MRCP+ results on a physicians' diagnosis and/or plans for care of patients with suspected or confirmed PSC compared with usual standard of care.

  8 months

Secondary Outcomes (1)

• Cost effectiveness of using enhanced MRCP (MRCP+) for diagnosis and monitoring of PSC patients

  12 months

Study Arms (1)

PSC patients attending outpatient

Primary sclerosing cholangitis, as defined by EASL and AASLD guidelines.

Device: Quantitative Multi parametric MRI and enhanced MRCP

Interventions

Quantitative Multi parametric MRI and enhanced MRCP DEVICE

Patients will have quantitative MRI and enhanced MRCP on addition to their standard of care

PSC patients attending outpatient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 adult participants will be recruited who are over the age of 18 and are attending a hepatology appointment at UHB and are either being investigated for PSC or have confirmed PSC.

You may qualify if:

• Adult patients aged 18 years or over
• Patient due to attend the hepatology clinic for PSC diagnostics/review
• Participant is willing and able to give informed consent

You may not qualify if:

• The participants may not enter the study if they have any contraindication to magnetic resonance imaging (including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
• Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study

Sponsors & Collaborators

• Perspectum: lead
• University of Birmingham: collaborator

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: December 21, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share