Clinical trial NCT01234701: Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Keywords: Liver
Neoplasms
Magnetic Resonance Imaging
Surgery
Pathology
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Harvard University
name: University Hospital, Essen
name: Auckland City Hospital
name: University Hospital, Strasbourg, France
name: The Leeds Teaching Hospitals NHS Trust
name: Imperial College London
name: University College London Hospitals
name: St. Louis University
First posted: 2010-11-04
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinics

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.

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 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.

Primary outcomes:
measure: Inter-observer agreement among expert radiologists in diagnosing primary liver tumors by Magnetic Resonance Imaging (MRI).
timeFrame: December 2010
Secondary outcomes:
measure: Agreement of radiologists with the actual diagnosis of primary liver tumors assessed by Magnetic Resonance Imaging (MRI).
timeFrame: December 2010
measure: Differences in radiologist' certainty of diagnosis (CoD) among different tumor types.
timeFrame: December 2010
measure: Intra-class correlation coefficient among radiologists' Certainty of Diagnosis (CoD) in diagnosis primary liver tumors by Magnetic Resonant Imaging (MRI)
timeFrame: December 2010
measure: Investigate the diagnostic efficacy of radiologists' certainty of diagnosis (CoD) in accurately predicting primary liver tumors assessed by Magnetic Resonant Imaging (MRI)
timeFrame: December 2010
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Medical School, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis University, Liver Center
state: Missouri
city: Strasbourg
country: France
facility: University Hospital Strasbourg
state: Cedex
city: Essen
country: Germany
facility: University Hospital Essen
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Interventional and Diagnostic Radiology
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College, Hammersmith Hospital
Study officials:
affiliation: University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
name: Stefan Breitenstein, MD
role: PRINCIPAL_INVESTIGATOR
References: