Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI) (MRevaluation)
This study has been completed.
Sponsor:
University of Zurich
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
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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 May 19, 2013