We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Neoplasms 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 Design

Study Type : Observational
Actual Enrollment : 108 participants
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
Study Start Date : October 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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 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.


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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 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
United Kingdom
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
Sponsors and Collaborators
University of Zurich
Harvard University
University Hospital, Essen
Auckland City Hospital
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:
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01234701     History of Changes
Other Study ID Numbers: MRI_Liver_Tumours_Evlauation
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics