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

NCT ID: NCT01234701

Last Updated: 2012-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Non-invasive Magnetic Resonance Imaging (MRI)

Intervention Type OTHER

Conventional pre-operative MRI

Liver resection

Intervention Type PROCEDURE

Hepatectomy with an intention to cure

Histopathology diagnosis of resected liver specimen

Intervention Type OTHER

Histopathology diagnosis by expert pathologist.

Interventions

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Non-invasive Magnetic Resonance Imaging (MRI)

Conventional pre-operative MRI

Intervention Type OTHER

Liver resection

Hepatectomy with an intention to cure

Intervention Type PROCEDURE

Histopathology diagnosis of resected liver specimen

Histopathology diagnosis by expert pathologist.

Intervention Type OTHER

Other Intervention Names

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Magnetic Resonance Imaging Hepatectomy = liver resection by open surgery. Examination under the microscope.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard University

OTHER

Sponsor Role collaborator

University Hospital, Essen

OTHER

Sponsor Role collaborator

Auckland City Hospital

OTHER_GOV

Sponsor Role collaborator

University Hospital, Strasbourg, France

OTHER

Sponsor Role collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

University College London Hospitals

OTHER

Sponsor Role collaborator

St. Louis University

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Breitenstein, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland

Locations

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Harvard Medical School, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

St. Louis University, Liver Center

St Louis, Missouri, United States

Site Status

University Hospital Strasbourg

Strasbourg, Cedex, France

Site Status

University Hospital Essen

Essen, , Germany

Site Status

Auckland City Hospital

Auckland, Auckland, New Zealand

Site Status

University Hospital Zurich, Department of Interventional and Diagnostic Radiology

Zurich, Canton of Zurich, Switzerland

Site Status

University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center

Zurich, Canton of Zurich, Switzerland

Site Status

The Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

Site Status

Imperial College, Hammersmith Hospital

London, , United Kingdom

Site Status

Countries

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United States France Germany New Zealand Switzerland United Kingdom

Related Links

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http://en.wikipedia.org/wiki/Inter-rater_reliability

Inter-rater reliability (also called: inter-rater agreement, or concordance) definitions and further information

Other Identifiers

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MRI_Liver_Tumours_Evlauation

Identifier Type: -

Identifier Source: org_study_id

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