Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI) (MRevaluation)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01234701|
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : May 28, 2012
|Condition or disease||Intervention/treatment|
|Neoplasms||Other: Non-invasive Magnetic Resonance Imaging (MRI) Procedure: Liver resection Other: Histopathology diagnosis of resected liver specimen|
|Study Type :||Observational|
|Actual Enrollment :||108 participants|
|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|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
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 ImagingProcedure: 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.
- Inter-observer agreement among expert radiologists in diagnosing primary liver tumors by Magnetic Resonance Imaging (MRI). [ Time Frame: December 2010 ]Inter-observer agreement for categorical data will by assessed by the Fliess' kappa (good agreement >0.7).
- Agreement of radiologists with the actual diagnosis of primary liver tumors assessed by Magnetic Resonance Imaging (MRI). [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: December 2010 ]Diagnostic efficacy will be assessed by Receiver Operating Characteristic (ROC) Curves.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234701
|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|
|University Hospital Strasbourg|
|Strasbourg, Cedex, France, 67098|
|University Hospital Essen|
|Essen, Germany, 45147|
|Auckland City Hospital|
|Auckland, New Zealand, 9|
|University Hospital Zurich, Department of Interventional and Diagnostic Radiology|
|Zurich, Switzerland, 8091|
|University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center|
|Zurich, Switzerland, 8091|
|The Leeds Teaching Hospitals NHS Trust|
|Leeds, United Kingdom, LS9 7TF|
|University College London Hospitals NHS Foundation Trust|
|London, United Kingdom, NW1 2PG|
|Imperial College, Hammersmith Hospital|
|London, United Kingdom, W12 0HS|
|Principal Investigator:||Stefan Breitenstein, MD||University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland|