Non-Invasive rapid assessment of patients with liver transplants using Magnetic Resonance Imaging with LiverMultiScan

Non-Invasive rapid assessment of patients with liver transplants using Magnetic Resonance Imaging with LiverMultiScan - RADIcAL 2 study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45260

Enrollment

Registered

2017-07-13

Start date

2017-12-05

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

de novo or recurrent graft rejection of post-transplanted liver - liver failure

Interventions

Liver

Liver biopsy

Multiparametric quantitative MRI

Transplantation

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patient over 18 years old with a liver transplant. - Patient due to undergo routine liver biopsy or biopsy for suspected pathology after liver transplantation

Exclusion criteria

Exclusion criteria: - Any contraindication to magnetic resonance imaging (inc pregnancy, pacemaker, shrapnel injury, severe claustrophobia). - Any contraindication to liver biopsy (coagulopathy, obstructed biliary tract with high risk bile leak, ascites etc) - Patients who are unable to tolerate MRI without sedation or general anaesthetic

Design outcomes

Primary

Measure	Time frame
The liver iron, liver fat, cardiovascular function and the Liver Inflammation Fibrosis scores (LIF) compared to biopsy results for iron, fat, fibroinflammatory status and rejection	—

Secondary

Measure	Time frame
- Patient feedback from qualitative research - Concordance between MR measurements of fibrosis/rejection and elastography/blood tests - Comparison of LIF with clinical diagnosis using blood tests and liver histology	—

Countries

Germany, Netherlands, Portugal, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)