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

Completed

• Conditions: Neoplasms
• Interventions: Other: Non-invasive Magnetic Resonance Imaging (MRI); Procedure: Liver resection; Other: Histopathology diagnosis of resected liver specimen

• Registration Number: NCT01234701
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary liver tumors, non-cirrhotic	Non-invasive Magnetic Resonance Imaging (MRI)	This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonance Imaging (MRI) and underwent resection for primary liver tumors.
Primary liver tumors, non-cirrhotic	Liver resection	This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonance Imaging (MRI) and underwent resection for primary liver tumors.
Primary liver tumors, non-cirrhotic	Histopathology diagnosis of resected liver specimen	This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonance Imaging (MRI) and underwent resection for primary liver tumors.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.

Trial Locations

Locations (10)

St. Louis University, Liver Center; 🇺🇸 Saint Louis, Missouri, United States

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

The Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom

University Hospital Zurich, Department of Interventional and Diagnostic Radiology; 🇨🇭 Zurich, Switzerland

University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center; 🇨🇭 Zurich, Switzerland

University Hospital Essen; 🇩🇪 Essen, Germany

University Hospital Strasbourg; 🇫🇷 Strasbourg, Cedex, France

Imperial College, Hammersmith Hospital; 🇬🇧 London, United Kingdom

Harvard Medical School, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University College London Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom