*T1-mapping for functional MR imaging of the liver in Primary Sclerosing Cholangitis

Completed

• Conditions: Primary Sclerosing Cholangitis; 10019654; Bile duct inflammation

• Registration Number: NL-OMON40638
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

- 18 years or older
- Proven prior diagnosis of Primary Sclerosing Cholangitis (based on laboratory and clinical findings and biopsy and/or ERCP and/or MRCP results)
- Clinically suspected dominant stricture causing acute pruritus and jaundice with indication for urgent MRCP and ERCP
- Written, informed consent

Exclusion Criteria

- Contraindications for MRI
- Known haemochromatosis
- Chronic renal insufficiency or eGFR < 30 ml/min/1.73 m2
- Known or family history of congenital prolonged QT-syndrome
- Prior history of arrhythmia after the use of cardiac repolarisation time prolonging drugs
- Current use of cardiac repolarisation time prolonging drugs (such as class 3 anti-arrhythmic drugs (such as amiodaron or sotalol)
- Prior history of allergic reaction to gadolinium-containing compounds
- Prior history of asthma bronchiale
- Current use of beta blockers

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Quantitative MRI: *T1<br /><br>- MRCP/ERCP: location and degree of bile duct obstruction</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Laboratory values: e.g. AP, gGT, billirubin (as measure of cholestasis)<br /><br>- Liver fat percentages (MR fat mapping)<br /><br>- Bile composition (using in vitro, high-field MR Spectroscopy)</p><br>