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

University of Zurich108 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

Neoplasms

Interventions

Non-invasive Magnetic Resonance Imaging (MRI)OTHER

Conventional pre-operative MRI

Liver resectionPROCEDURE

Hepatectomy with an intention to cure

Histopathology diagnosis of resected liver specimenOTHER

Histopathology diagnosis by expert pathologist.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (10)

Harvard Medical School, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

St. Louis University, Liver Center

St Louis, Missouri, United States

University Hospital Strasbourg

Strasbourg, Cedex, France

Outcomes

Primary Outcomes

Inter-observer agreement among expert radiologists in diagnosing primary liver tumors by Magnetic Resonance Imaging (MRI).

Inter-observer agreement for categorical data will by assessed by the Fliess' kappa (good agreement \>0.7).

Time frame: December 2010

Secondary Outcomes

Agreement of radiologists with the actual diagnosis of primary liver tumors assessed by Magnetic Resonance Imaging (MRI).

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).

Time frame: December 2010

Differences in radiologist' certainty of diagnosis (CoD) among different tumor types.

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.

Time frame: December 2010

Intra-class correlation coefficient among radiologists' Certainty of Diagnosis (CoD) in diagnosis primary liver tumors by Magnetic Resonant Imaging (MRI)

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.

Time frame: December 2010

Investigate the diagnostic efficacy of radiologists' certainty of diagnosis (CoD) in accurately predicting primary liver tumors assessed by Magnetic Resonant Imaging (MRI)

Diagnostic efficacy will be assessed by Receiver Operating Characteristic (ROC) Curves.

Time frame: December 2010

Data from ClinicalTrials.gov

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