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NCT Number: NCT01234701

Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI)

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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Key information

Conditions

Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Strasbourg, Strasbourg, Cedex, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive Magnetic Resonance Imaging (MRI)

Other

Conventional pre-operative MRI

Other names: Magnetic Resonance Imaging

liver resection

Procedure

Hepatectomy with an intention to cure

Other names: Hepatectomy = liver resection by open surgery.

Histopathology diagnosis of resected liver specimen

Other

Histopathology diagnosis by expert pathologist.

Other names: Examination under the microscope.

Primary outcomes

  1. Inter-observer agreement among expert radiologists in diagnosing primary liver tumors by Magnetic Resonance Imaging (MRI).

    Time frame: December 2010

    Inter-observer agreement for categorical data will by assessed by the Fliess' kappa (good agreement >0.7).

Secondary outcomes

  1. Agreement of radiologists with the actual diagnosis of primary liver tumors assessed by Magnetic Resonance Imaging (MRI).

    Time frame: December 2010

    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).

  2. Differences in radiologist' certainty of diagnosis (CoD) among different tumor types.

    Time frame: December 2010

    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.

  3. Intra-class correlation coefficient among radiologists' Certainty of Diagnosis (CoD) in diagnosis primary liver tumors by Magnetic Resonant Imaging (MRI)

    Time frame: December 2010

    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.

  4. 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

    Diagnostic efficacy will be assessed by Receiver Operating Characteristic (ROC) Curves.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Auckland City Hospital
  • Harvard University
  • Imperial College London
  • St. Louis University
  • The Leeds Teaching Hospitals NHS Trust
  • University College London Hospitals
  • University Hospital, Essen
  • University Hospital, Strasbourg, France

Registry information

Official study 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

Acronym: MRevaluation

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 4, 2010
Registry last updated
May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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