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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01234701
Registration number
NCT01234701
Ethics application status
Date submitted
3/11/2010
Date registered
4/11/2010
Date last updated
28/05/2012
Titles & IDs
Public title
Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI)
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Scientific 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
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Secondary ID [1]
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MRI_Liver_Tumours_Evlauation
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Universal Trial Number (UTN)
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Trial acronym
MRevaluation
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms
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Condition category
Condition code
Cancer
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Liver
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Non-invasive Magnetic Resonance Imaging (MRI)
Treatment: Surgery - Liver resection
Other interventions - Histopathology diagnosis of resected liver specimen
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 interventions: Non-invasive Magnetic Resonance Imaging (MRI)
Conventional pre-operative MRI
Treatment: Surgery: Liver resection
Hepatectomy with an intention to cure
Other interventions: Histopathology diagnosis of resected liver specimen
Histopathology diagnosis by expert pathologist.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Inter-observer agreement among expert radiologists in diagnosing primary liver tumors by Magnetic Resonance Imaging (MRI).
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Assessment method [1]
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Inter-observer agreement for categorical data will by assessed by the Fliess' kappa (good agreement >0.7).
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Timepoint [1]
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December 2010
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Secondary outcome [1]
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Agreement of radiologists with the actual diagnosis of primary liver tumors assessed by Magnetic Resonance Imaging (MRI).
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Assessment method [1]
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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).
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Timepoint [1]
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December 2010
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Secondary outcome [2]
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Differences in radiologist' certainty of diagnosis (CoD) among different tumor types.
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Assessment method [2]
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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.
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Timepoint [2]
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December 2010
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Secondary outcome [3]
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Intra-class correlation coefficient among radiologists' Certainty of Diagnosis (CoD) in diagnosis primary liver tumors by Magnetic Resonant Imaging (MRI)
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Assessment method [3]
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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.
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Timepoint [3]
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December 2010
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Secondary outcome [4]
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Investigate the diagnostic efficacy of radiologists' certainty of diagnosis (CoD) in accurately predicting primary liver tumors assessed by Magnetic Resonant Imaging (MRI)
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Assessment method [4]
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Diagnostic efficacy will be assessed by Receiver Operating Characteristic (ROC) Curves.
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Timepoint [4]
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December 2010
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Other histopathological diagnosis such as cysts and hemangiomas.
- Patient age less than 18 years of age.
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2012
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Sample size
Target
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Accrual to date
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Final
108
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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United States of America
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State/province [2]
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Missouri
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France
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State/province [3]
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Cedex
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Germany
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State/province [4]
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Essen
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Country [5]
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New Zealand
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State/province [5]
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Auckland
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Country [6]
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Switzerland
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State/province [6]
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Zurich
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Country [7]
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United Kingdom
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State/province [7]
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Leeds
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Country [8]
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United Kingdom
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State/province [8]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Zurich
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Harvard University
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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University Hospital, Essen
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Auckland City Hospital
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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University Hospital, Strasbourg, France
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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The Leeds Teaching Hospitals NHS Trust
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Address [5]
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Other collaborator category [6]
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Other
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Name [6]
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Imperial College London
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Address [6]
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Other collaborator category [7]
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Other
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Name [7]
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University College London Hospitals
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Address [7]
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Other collaborator category [8]
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Other
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Name [8]
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St. Louis University
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Address [8]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01234701
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stefan Breitenstein, MD
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Address
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University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01234701
Download to PDF