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

Neoplasms Clinical Trial

— MRevaluation  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234701
• Other study ID #: MRI_Liver_Tumours_Evlauation
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: May 25, 2012
• Start date: October 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neoplasms

Intervention

Other:
• Non-invasive Magnetic Resonance Imaging (MRI)
Conventional pre-operative MRI

Procedure:
• Liver resection
Hepatectomy with an intention to cure

Other:
• Histopathology diagnosis of resected liver specimen
Histopathology diagnosis by expert pathologist.

Locations

Country	Name	City	State
France	University Hospital Strasbourg	Strasbourg	Cedex
Germany	University Hospital Essen	Essen
New Zealand	Auckland City Hospital	Auckland
Switzerland	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
United Kingdom	The Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Imperial College, Hammersmith Hospital	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London
United States	Harvard Medical School, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	St. Louis University, Liver Center	Saint Louis	Missouri

Sponsors (9)

Lead Sponsor	Collaborator
University of Zurich	Auckland City Hospital, Harvard University, Imperial College London, St. Louis University, The Leeds Teaching Hospitals NHS Trust, University College London Hospitals, University Hospital, Essen, University Hospital, Strasbourg, France

Countries where clinical trial is conducted

United States,  France,  Germany,  New Zealand,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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