|- candidate number||8393|
|- NTR Number||NTR2489|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-aug-2010|
|- Secondary IDs||09/127 / 0904-014 ; MEC AMC / Fonds Nuts-Ohra |
|- Public Title||Liver stiffness measurement with MR Elastography.|
|- Scientific Title||MR Elastography for the non-invasive assessment of liver fibrosis in patients with chronic viral liver disease compared with FibroScan and liver biopsy.|
|- hypothesis||MR Elastography can be used as a non-invasive tool to diagnose, stage and monitor liver fibrosis.
MR Elastography has a better accuracy than FibroScan for the assessment of intermediate fibrosis stages. |
|- Healt Condition(s) or Problem(s) studied||Hepatitis C, Hepatitis B, MRI, Elastography, Liver|
|- Inclusion criteria||1. Patients over 18 years of age;|
2. Have viral hepatitis B or C;
3. Recently (< 6 weeks ago) had a liver biopsy or who are scheduled for liver biopsy.
|- Exclusion criteria||1. Patients with an alcohol intake for >3 units per day for males and >2 units per day for females;|
2. Patients who are pregnant, claustrophobic, who have magnetic or radiofrequent implants;
3. Patients with extreme obesity.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||13-nov-2009|
|- planned closingdate||1-jun-2011|
|- Target number of participants||83|
|- Interventions||Consenting patients will undergo an MRI scan of the liver (MR Elastography and MR Spectroscopy measurement). Standard clinical practice includes liver biopsy and FibroScan measurement. Liver biopsy is used as reference standard. The MRI reader is blinded to the results of the liver biopsy.
All patients will fill out a questionnaire to evaluate the burden of MR Elastography, Fibroscan and liver biopsy.
|- Primary outcome||The accuracy of MR elastography for fibrosis measurement compared with FibroScan and liver biopsy. |
|- Secondary outcome||1. The influence of hepatic fat content and inflammation on MR Elastography measurement;|
2. The evaluation of anti-viral treatment response with MR Elastography.
|- Timepoints||The MRI scan, Fibroscan and liver biopsy have to be performed within a timeframe of 6 weeks. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. A.E. Bohte|
|- CONTACT for SCIENTIFIC QUERIES||MD. A.E. Bohte|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||The prognosis of patients with chronic liver disease depends to a high degree on the presence and degree of liver fibrosis. In this respect determination of different degrees of liver fibrosis is crucial for the management of chronic liver disease. Liver biopsy is the current gold standard for diagnosing chronic liver disease. However, liver biopsy is accompanied by the risk of complications, patient discomfort and poor reproducibility due to sampling errors. Transient Elastography (FibroScan) is now used as a non-invasive alternative to detect liver fibrosis by measuring liver stiffness. This ultrasound technique can differentiate between severe liver fibrosis and no fibrosis, but is not sensitive enough to measure intermediate degrees of liver fibrosis.
Magnetic Resonance Elastography (MRE) has been introduced as a new and accurate non-invasive method to determine liver fibrosis. MRE provides reproducible visco-elastic information of the whole liver, and is not prone to sampling errors. Up to date a few clinical studies have investigated the accuracy of MRE. However, these studies were conducted in heterogeneous patient groups. At this moment it is not clear whether these findings can be applied unconditionally to specific patient groups such as patients with viral hepatitis B and C. We will therefore evaluate the accuracy of MRE compared with FibroScan and liver biopsy in patients with hepatitis B and C.
We considered patients with a fibrosis stage of F2, F3 or F4 as diseased. A fibrosis stage of F0 or F1 was considered non-diseased. Given the reported sensitivity of 92% for MRE and 75.4% for FibroScan for detection of fibrosis stage of F2 or higher, a minimum number of 50 patients is required in this group. Given a prevalence of 60% of patients with fibrosis stage F2, F3 or F4, we need to include a total number of 83 patients in this study over an 18 month inclusion period.
|- Main changes (audit trail)|
|- RECORD||31-aug-2010 - 9-sep-2010|