Evaluation of the CAP-value for quantitating liver steatosis using 1H-MRS and liver biopsy as reference standard

Evaluation of the CAP-value for quantitating liver steatosis using 1H-MRS and liver biopsy as reference standard - CAPtivating

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41661

Enrollment

Registered

2012-12-04

Start date

2013-03-28

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

fatty liver Liver steatosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: - 18 years or older - Liver biopsy performed within 6 weeks of visit 1 - FibroScan examination possible with M-probe - Written, informed consent;Healty volunteers: - 18 years or older - No history of liver disease - FibroScan examination possible with M-probe - Written informed consent

Exclusion criteria

Exclusion criteria: For all subjects: - Alcohol consumption of >3 units per day for male and >2 units per day for females - Focal liver lesion(s) in the right liver lobe (proven with histology results or imaging) - Contra-indications for MRI scanning (except cohort B) - 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 - 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 measurements or - for the subset of cohort A - in between visit 1 and visit 2 - Known hemochromatosis;For healthy volunteers: - CAP-value of 300 or more (measured as part of screening visit after informed consent)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Inter- and intraobserver variability for CAP-values (at visit 1) Reproducibility (within-session and within-weeks) for CAP-values (visit 1 and 2) Correlation between CAP-values and liver viscosity values found at MRE Correlation between TE-values (FibroScan) and Elastography-values found at MRE Correlation between CAP-values and fat percentage at MRI-based liver fatmaps Effect of a standardized amount of fat intake on CAP-values Perceived burden and patient preference	—

Measure

Time frame

Inter- and intraobserver variability for CAP-values (at visit 1) Reproducibility (within-session and within-weeks) for CAP-values (visit 1 and 2) Correlation between CAP-values and liver viscosity values found at MRE Correlation between TE-values (FibroScan) and Elastography-values found at MRE Correlation between CAP-values and fat percentage at MRI-based liver fatmaps Effect of a standardized amount of fat intake on CAP-values Perceived burden and patient preference

—

Countries

Netherlands

Outcome results