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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01234701




Registration number
NCT01234701
Ethics application status
Date submitted
3/11/2010
Date registered
3/11/2010
Date last updated
25/05/2012

Titles & IDs
Public title
Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI)
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
Secondary ID [1] 0 0
MRI_Liver_Tumours_Evlauation
Universal Trial Number (UTN)
Trial acronym
MRevaluation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
December 2010
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
December 2010
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
December 2010
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
December 2010
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
December 2010

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
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Other histopathological diagnosis such as cysts and hemangiomas.

- Patient age less than 18 years of age.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
France
State/province [3] 0 0
Cedex
Country [4] 0 0
Germany
State/province [4] 0 0
Essen
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
Switzerland
State/province [6] 0 0
Zurich
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Leeds
Country [8] 0 0
United Kingdom
State/province [8] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
University of Zurich
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Harvard University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University Hospital, Essen
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Auckland City Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University Hospital, Strasbourg, France
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
The Leeds Teaching Hospitals NHS Trust
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Imperial College London
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
University College London Hospitals
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
St. Louis University
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01234701
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stefan Breitenstein, MD
Address 0 0
University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications