|- candidate number||14275|
|- NTR Number||NTR3834|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-jan-2013|
|- Secondary IDs||NL41865.018.12 / 2012_310; CCMO / METC AMC|
|- Public Title||A new patient friendly liver fat measurement (CAP) compared with liver biopsy and MRI results.|
|- Scientific Title||Evaluation of the CAP-value for quantitating liver steatosis using 1H-MRS and liver biopsy as reference standard.|
|- hypothesis||Hepatic steatosis is becoming a large health burden in both Western and non-Western
societies. There is a need for specific diagnostic tools that can distinguish between patients with significant steatosis and those without whilst simultaneously quantifying the amount of steatosis. Quantification will help clinicians to guide therapy. Several tools exist, but all suffer from shortcomings. A new tool for quantifying steatosis is the Controlled Attenuation Parameter (CAP),
available on the FibroScan® (a device used to determine the presence of liver fibrosis). This tool gives a continuous outcome measure and has thus far been evaluated mainly against semi-quantitative scoring
of liver biopsies and not against other continuous outcome measures such as 1H-MR Spectroscopy or MRI based liver fat-maps. We hypothesize that CAP-values correlate with fat percentages found at
1H-MR Spectroscopy and that CAP-values can be used in daily practice for reproducible and accurate fat measurements.|
|- Healt Condition(s) or Problem(s) studied||Non alcoholic steato hepatitis (NASH), Magnetic resonance imaging (MRI) , Magnetic Resonance Spectroscopy (MRS), FibroScan, Hepatic steatosis|
|- Inclusion criteria||1. Male or Female Sex;|
2. 18 years or older;
3. Liver biopsy performed in AMC or participating centers within 6 weeks from visit 1;
4. FibroScan-measurement possible with M-probe.
|- Exclusion criteria||1. Alcohol consumption of >3 units per day for male and >2 units per day for females*;|
2. Focal liver lesion(s) in the right liver lobe (proven with histology results or imaging);
3. Contra-indications for MRI scanning;
4. Start of or change in treatment of liver disease less than 4 weeks before visit 1 or liver biopsy (whichever comes first) or - for the subset of cohort A - in between visit 1 and 2**;
5. Start of or change in use of medications known to have steatogenic effects on the liver (synthetic oestrogens, corticosteroids, diltiazem, nifedipine, perhexilline, amiodarone, metformin, insulin, statins,
rosiglitazon, methotrexate, antiretroviral therapy, tamoxifen, tetracycline, valproate less than 4 weeks before visit 1 or liver biopsy (whichever comes first) or - for the subset of cohort A - in between visit 1 and
6. Fibroscan®/CAP examination not possible with M-probe;
7. Known haemochromatosis***.
* Factors that can affect reproducibility over the proposed time interval of 2-4 weeks.
** Subjects are therefore not delayed in the treatment of their disease.
*** Excessive iron accumulation can cause MRI and MRE to fail.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-feb-2013|
|- planned closingdate||30-nov-2014|
|- Target number of participants||70|
|- Primary outcome||The correlation between CAP-values and fat percentage found at 1H-MR Spectroscopy of the right liver lobe and steatosis grade at liver biopsy.|
|- Secondary outcome||1. Inter- and intraobserver variability for CAP-values (at visit 1);|
2. Reproducibility (within-session and within-weeks) for CAP-values (visit 1 and 2);
3. Correlation between CAP-values and liver viscosity values found at MRE;
4. Correlation between TE-values (FibroScan) and Elastography-values found at MRE;
5. Correlation between CAP-values and fat percentage at MRI-based liver fatmaps;
6. Perceived burden and patient preference (questionnaire).
|- Timepoints||Cohort A (all 70 subjects):|
1. CAP-value (and TE-value) with FibroScan device (measured twice at visit 1, within 6 weeks from liver biopsy);
2. Liver fat fraction and Elastography-values (measured with MRI at visit 1);
3. Burden and preference (questionnaire given at the end of visit 1).
Cohort A (30 of all 70 subjects):
1. CAP-value (and TE-value) with FibroScan device (measured at visit 2, two to four weeks after visit 1);
2. Liver fat fraction and Elastography-values with MRI (measured at visit 2).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Jurgen Runge|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J. Stoker|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Radiology|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Department of Radiology|
|- Brief summary||CAPtivating is a study in which the CAP-measurement of liver fat content is compared to two reference standards for liver fat: histology and MR-based liver fat fractions. 70 subjects with recent liver biopsies are included and receive both CAP-measurement and a MRI-scan on one day. In a substudy, 30 subjects come back for a second visit to assess the reproducibility of the measurements.
All subjects are recruited in the Netherlands (in the AMC and participating centers).
|- Main changes (audit trail)|
|- RECORD||29-jan-2013 - 19-apr-2013|