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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neoplasms

Intervention / Treatment
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* Other: Non-invasive Magnetic Resonance Imaging (MRI)
* Procedure: Liver resection
* Other: Histopathology diagnosis of resected liver specimen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary liver tumors, non-cirrhotic<br>This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonance Imaging (MRI) and underwent resection for primary liver tumors. | Other: Non-invasive Magnetic Resonance Imaging (MRI)<br>* Conventional pre-operative MRI<br>* Other names: Magnetic Resonance Imaging;Procedure: Liver resection<br>* Hepatectomy with an intention to cure<br>* Other names: Hepatectomy = liver resection by open surgery.;Other: Histopathology diagnosis of resected liver specimen<br>* Histopathology diagnosis by expert pathologist.<br>* Other names: Examination under the microscope.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | December 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | December 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver, Neoplasms, Magnetic Resonance Imaging, Surgery, Pathology