Clinical Application of Annual Liver Multiscan and MRCP+ in Primary Sclerosing Cholangitis
Not applicable · Testing Liver Multiscan sequences, Liver Multiscan analysis and MRCP+ · Sites not listed yet · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Liver Multiscan sequences (a device), Liver Multiscan analysis (a device) and MRCP+ (a device) as a way to diagnose or measure disease. Condition(s) listed: Primary Sclerosing Cholangitis.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Established PSC diagnosis according to the IPSCSG definitions
- Age ≥ 18
- Able to give informed consent
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- The study has 1 group.
- Start date: 2022-07 (planned).
- Main results expected around 2028-07 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Groups in this study
- Additional sequences with MRCP+ and LiverMultiscan
Main thing being measured
- Delta of cT1 in patients with PSC during follow-up (1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th…)
In the researchers’ words
Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease that affects approximately 1200 patients in the Netherlands and around 80,000 in the Western world. It is often accompanied by ulcerative colitis (UC) or Crohn's disease affecting the large bowel. The cause of PSC is unknown, there is no medical therapy available that has proven to halt disease progression and the median time until death…
Words you might see
- MRCP: an MRI scan of the bile ducts and pancreas.
- Biopsy / histology: a small tissue sample examined under a microscope.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Primary Sclerosing Cholangitis |
| Lead sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Collaborators | Perspectum |
| Enrollment | 200 (estimated) |
| Start date | 2022-07 |
| Primary completion (est.) | 2028-07 |
| First posted | 2022-07-18 |
| Last updated | 2022-07-18 |
| Official title | Clinical Application of Annual Liver Multiscan and MRCP+ in Primary Sclerosing Cholangitis: the CATCH-IT Study |
| ClinicalTrials.gov ID | NCT05462093 |
Interventions
- Liver Multiscan sequences (Device)
Additional Liver Multiscan sequences will be performed after the MRI liver with MRCP is performed, taking approximately 15 minutes. - Liver Multiscan analysis (Device)
Post processing tool (Software) for determining the corrected T1 time after the additional LMS sequences at baseline are performed. This cT1 reflects the activity of inflammation/fibrosis of the liver. Patient involvement is not necessary during this procedure. - MRCP+ (Device)
Post processing tool (Software) for quantifying MRCP images after the MRCP from follow up is performed. Patient involvement is not necessary during this procedure.
Full eligibility criteria (from the record)
Inclusion Criteria: * Established PSC diagnosis according to the IPSCSG definitions * Age ≥ 18 * Able to give informed consent Exclusion Criteria: * Post LTx * Known allergy for MRI contrast agents, implants non-compatible with MRI or extreme claustrophobia causing discontinuation of MRI studies.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.