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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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).
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).
Timepoint [1] 0 0
December 2010
Secondary outcome [2] 0 0
Differences in radiologist' certainty of diagnosis (CoD) among different tumor types.
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)
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)
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
Sex
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
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
108
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
Government body
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/study/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01234701