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

November 3, 2010
May 25, 2012
October 2010
May 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01234701 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinics

Neoplasms
  • 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.
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.
Interventions:
  • Other: Non-invasive Magnetic Resonance Imaging (MRI)
  • Procedure: Liver resection
  • Other: Histopathology diagnosis of resected liver specimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   New Zealand,   Switzerland,   United Kingdom
 
NCT01234701
MRI_Liver_Tumours_Evlauation
Yes
University of Zurich
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
Principal Investigator: Stefan Breitenstein, MD University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
University of Zurich
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP