Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI)

Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI) in Non-Cirrhotic Patients - A Double Blind International Multicenter Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01234701

Acronym

MRevaluation

Enrollment

108

Registered

2010-11-04

Start date

2010-10-31

Completion date

2012-05-31

Last updated

2012-05-28

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

Conditions

Neoplasms

Keywords

Liver, Neoplasms, Magnetic Resonance Imaging, Surgery, Pathology

Brief summary

The purpose of this multicenter study is to evaluate the agreement among expert radiologists in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in non-cirrhotic patients.

Detailed description

Magnetic Resonance Imaging (MRI) is currently the method of choice for non-invasive diagnosis of primary liver tumors. However, differentiation of hepatocellular carcinoma (HCC) from adenoma and focal nodular hyperplasia (FNH) remains challenging, particularly in non-cirrhotic patients.

Interventions

OTHERNon-invasive Magnetic Resonance Imaging (MRI)

Conventional pre-operative MRI

PROCEDURELiver resection

Hepatectomy with an intention to cure

OTHERHistopathology diagnosis of resected liver specimen

Histopathology diagnosis by expert pathologist.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Histopathological diagnosis of Hepatocellular Cancer (HCC), Adenoma and/or Focular nodular hyperplasia (FNH). * Patients that received a pre-operative Magnetic Resonance Imaging (MRI). * Patients that underwent liver resection with an intention to cure. * Patient over 18 years of age

Exclusion criteria

* Other histopathological diagnosis such as cysts and hemangiomas. * Patient age less than 18 years of age.

Design outcomes

Primary

Measure	Time frame	Description
Inter-observer agreement among expert radiologists in diagnosing primary liver tumors by Magnetic Resonance Imaging (MRI).	December 2010	Inter-observer agreement for categorical data will by assessed by the Fliess' kappa (good agreement \>0.7).

Secondary

Measure	Time frame	Description
Agreement of radiologists with the actual diagnosis of primary liver tumors assessed by Magnetic Resonance Imaging (MRI).	December 2010	The actual diagnosis is defined as the histopathology diagnosis of the resected liver specimen, the current gold standard technique. Such agreement will be assessed by Cohen's Kappa (good agreement \>0.7).
Investigate the diagnostic efficacy of radiologists' certainty of diagnosis (CoD) in accurately predicting primary liver tumors assessed by Magnetic Resonant Imaging (MRI)	December 2010	Diagnostic efficacy will be assessed by Receiver Operating Characteristic (ROC) Curves.
Differences in radiologist' certainty of diagnosis (CoD) among different tumor types.	December 2010	Radiologist' certainty of diagnosis (CoD) will be assessed by a Visual Analogue Scale (VAS 1-10). Potential differences in CoD will be identified by non-parametric multiple comparisons.
Intra-class correlation coefficient among radiologists' Certainty of Diagnosis (CoD) in diagnosis primary liver tumors by Magnetic Resonant Imaging (MRI)	December 2010	Intra-class correlation coefficient is a descriptive statistic that can be used when quantitative measurements are made on units that are organized into groups. It describes how strongly units in the same group resemble each other.

Countries

France, Germany, New Zealand, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026