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

This study has been completed.
Sponsor:
Collaborators:
Harvard University
University Hospital, Essen
Auckland City Hospital, New Zealand
University Hospital, Strasbourg, France
The Leeds Teaching Hospitals NHS Trust
Imperial College London
University College London Hospitals
St. Louis University
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01234701
First received: November 3, 2010
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI) in Non-Cirrhotic Patients - A Double Blind International Multicenter Study

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Inter-observer agreement among expert radiologists in diagnosing primary liver tumors by Magnetic Resonance Imaging (MRI). [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    Inter-observer agreement for categorical data will by assessed by the Fliess' kappa (good agreement >0.7).


Secondary Outcome Measures:
  • Agreement of radiologists with the actual diagnosis of primary liver tumors assessed by Magnetic Resonance Imaging (MRI). [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    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. [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    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) [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    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) [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    Diagnostic efficacy will be assessed by Receiver Operating Characteristic (ROC) Curves.


Enrollment: 108
Study Start Date: October 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Magnetic Resonance Imaging
Procedure: Liver resection
Hepatectomy with an intention to cure
Other Name: Hepatectomy = liver resection by open surgery.
Other: Histopathology diagnosis of resected liver specimen
Histopathology diagnosis by expert pathologist.
Other Name: Examination under the microscope.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinics

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234701

Locations
United States, Massachusetts
Harvard Medical School, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02117-0825
United States, Missouri
St. Louis University, Liver Center
Saint Louis, Missouri, United States, 63110-0250
France
University Hospital Strasbourg
Strasbourg, Cedex, France, 67098
Germany
University Hospital Essen
Essen, Germany, 45147
New Zealand
Auckland City Hospital
Auckland, New Zealand, 9
Switzerland
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
Zurich, Switzerland, 8091
United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Imperial College, Hammersmith Hospital
London, United Kingdom, W12 0HS
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Sponsors and Collaborators
University of Zurich
Harvard University
University Hospital, Essen
Auckland City Hospital, New Zealand
University Hospital, Strasbourg, France
The Leeds Teaching Hospitals NHS Trust
Imperial College London
University College London Hospitals
St. Louis University
Investigators
Principal Investigator: Stefan Breitenstein, MD University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
  More Information

Additional Information:
No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01234701     History of Changes
Other Study ID Numbers: MRI_Liver_Tumours_Evlauation
Study First Received: November 3, 2010
Last Updated: May 25, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Liver
Neoplasms
Magnetic Resonance Imaging
Surgery
Pathology

Additional relevant MeSH terms:
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014