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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• France
  • Cedex
    • Strasbourg, Cedex, France, 67098
      • University Hospital Strasbourg
• Germany
  • Essen, Germany, 45147
    • University Hospital Essen
• New Zealand
  • Auckland, New Zealand, 9
    • Auckland City Hospital
• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
  • Zurich, Switzerland, 8091
    • University Hospital Zurich, Department of Interventional and Diagnostic Radiology
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • The Leeds Teaching Hospitals Nhs Trust
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHS Foundation Trust
  • London, United Kingdom, W12 0HS
    • Imperial College, Hammersmith Hospital
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02117-0825
      • Harvard Medical School, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110-0250
      • St. Louis University, Liver Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinics

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Primary liver tumors, non-cirrhotic; 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); Conventional pre-operative MRI; Other Names: Magnetic Resonance Imaging; Procedure: Liver resection; Hepatectomy with an intention to cure; Other Names: Hepatectomy = liver resection by open surgery.; Other: Histopathology diagnosis of resected liver specimen; Histopathology diagnosis by expert pathologist.; Other Names: Examination under the microscope.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: University Hospital, Strasbourg, France; University College London Hospitals; University Hospital, Essen; Imperial College London; The Leeds Teaching Hospitals NHS Trust; Harvard University; St. Louis University; Auckland City Hospital
• Investigators: Principal Investigator: Stefan Breitenstein, MD, University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland

Publications and helpful links

Helpful Links

• Inter-rater reliability (also called: inter-rater agreement, or concordance) definitions and further information
• Fleiss' kappa information
• Cohen's kappa information
• Intraclass correlation information

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: November 3, 2010
• First Submitted That Met QC Criteria: November 3, 2010
• First Posted (Estimate): November 4, 2010

Study Record Updates

• Last Update Posted (Estimate): May 28, 2012
• Last Update Submitted That Met QC Criteria: May 25, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Surgery; Neoplasms; Magnetic Resonance Imaging; Liver; Pathology
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplasms; Liver Neoplasms; Hematinics; Liver Extracts
• Other Study ID Numbers: MRI_Liver_Tumours_Evlauation