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

NCT01234701 | Completed DMC

• 1 other identifier: MRI_Liver_Tumours_Evlauation
• Study Type: observational
• Target: 108
• Locations: 6 countries
• Sites: 10

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.

Conditions

Neoplasms

Keywords

Liver; Neoplasms; Magnetic Resonance Imaging; Surgery; Pathology

Outcome Measures

Primary Outcomes (1)

• 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).

  December 2010

Secondary Outcomes (4)

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

  December 2010

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

  December 2010

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

  December 2010

• Investigate the diagnostic efficacy of radiologists' certainty of diagnosis (CoD) in accurately predicting primary liver tumors assessed by Magnetic Resonant Imaging (MRI)

  December 2010

Study Arms (1)

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: Non-invasive Magnetic Resonance Imaging (MRI); Procedure: Liver resection; Other: Histopathology diagnosis of resected liver specimen

Interventions

Non-invasive Magnetic Resonance Imaging (MRI) OTHER

Conventional pre-operative MRI

Also known as: Magnetic Resonance Imaging

Primary liver tumors, non-cirrhotic

Liver resection PROCEDURE

Hepatectomy with an intention to cure

Also known as: Hepatectomy = liver resection by open surgery.

Primary liver tumors, non-cirrhotic

Histopathology diagnosis of resected liver specimen OTHER

Histopathology diagnosis by expert pathologist.

Also known as: Examination under the microscope.

Primary liver tumors, non-cirrhotic

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinics

You may qualify if:

• 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

You may not qualify if:

• Other histopathological diagnosis such as cysts and hemangiomas.
• Patient age less than 18 years of age.

Sponsors & Collaborators

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

Study Sites (10)

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

Boston, Massachusetts, 02117-0825, United States

Location

St. Louis University, Liver Center

St Louis, Missouri, 63110-0250, United States

Location

University Hospital Strasbourg

Strasbourg, Cedex, 67098, France

Location

University Hospital Essen

Essen, 45147, Germany

Location

Auckland City Hospital

Auckland, Auckland, 9, New Zealand

Location

University Hospital Zurich, Department of Interventional and Diagnostic Radiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

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

Zurich, Canton of Zurich, 8091, Switzerland

Location

The Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

Imperial College, Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Related Links

• Inter-rater reliability (also called: inter-rater agreement, or concordance) definitions and further information
• Fleiss' kappa information
• Cohen's kappa information
• Intraclass correlation information

MeSH Terms

Conditions

Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Hepatectomy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Stefan Breitenstein, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 4, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 28, 2012

Record last verified: 2012-05

Locations

US (2); FR (1); DE (1); NZ (1); CH (2); GB (3)