Detection Rate of Liver Metastases With Contrast Enhanced Intraoperative Ultrasound Compared to Regular Imaging (CEIOUS-Liver)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01522209
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : January 15, 2015
Information provided by (Responsible Party):
Dr. Gregor A. Stavrou, Asklepios Kliniken Hamburg GmbH

Brief Summary:
The study compares the established imaging techniques (CT, MRT, Contrast Ultrasound) with the new method of intraoperative contrast enhanced ultrasound to compare all methods for their rate of detection of colorectal liver metastasis.

Condition or disease Intervention/treatment Phase
Colon Cancer Liver Metastasis Contrast Enhances Intraoperative Ultrasound Imaging for Liver Cancer Imaging for Liver Metastasis Procedure: Liver Surgery Device: Contrast Enhanced Ultrasound Radiation: CT Scan (standard) Radiation: Primovist MRI (3 Tesla) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Value of Contrast Enhanced Intraoperative Ultrasound Compared to Preoperative CEUS, CT and MRT in the Treatment of Colorectal Liver Metastases.
Study Start Date : December 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Procedure: Liver Surgery
    R0 Resection of Liver Metastases after Planning with preoperative imaging data and comparison with intraoperative contrast enhanced ultrasound
    Device: Contrast Enhanced Ultrasound
    The contrast enhanced Ultrasound imaging is performed before and during the operation using Sonovue contrast agent (2.5ml iv preop, 4.5ml iv intraop)
    Radiation: CT Scan (standard)
    A staging CT of the liver/abdomen with the minimal possible dosage for aquiring sufficent triphasic data in a 64-line helical scan
    Radiation: Primovist MRI (3 Tesla)
    an MRI scan of the liver with Primovist contrast agent including late phase as addition to the preop staging according to the protocol

Primary Outcome Measures :
  1. Detection of Liver Metastasis during Operation [ Time Frame: During Operation ]
    Intraoperative Rate of Detection of Liver Metastasis compared to preoperative Imaging Analysis

Secondary Outcome Measures :
  1. Comparison of Detection Rate for Liver Metastases of all imaging modalities [ Time Frame: 1 Week after Operation ]
  2. Comparison of Sensitivity of all imaging modalities [ Time Frame: one Year ]
  3. Comparison of Specicivity of all imaging modalities [ Time Frame: one year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed Consent Age > 18 years All Patients presenting with Colorectal Liver Metastasis indicated for Liver Surgery in the study period

Exclusion Criteria:

  • No Informed Consent Possible Pregnancy Patients with hereditary diseases of the metabolic system Liver Cirrhosis CHILD B and C Renal Insufficiency defined as Kreatinin >2,5 mg/dl PAtients enrolled in other studies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01522209

Asklepios Hospital Barmbek
Hamburg, Germany, 22291
Sponsors and Collaborators
Asklepios Kliniken Hamburg GmbH
Principal Investigator: Gregor A Stavrou, Dpt. of General and Visceral Surgery, Asklepios Hospital Barmbek, Hamburg, Germany

Preim B, Bourquain H, Selle D, Oldhafer KJ. Resection Proposals for Oncologic Liver Surgery based on Vascular Territories. 2002 Mar. 8;
Robinson P. The early detection of liver metastases. Cancer Imaging. 2002;

Responsible Party: Dr. Gregor A. Stavrou, Principal Investigator, Asklepios Kliniken Hamburg GmbH Identifier: NCT01522209     History of Changes
Other Study ID Numbers: Asklepios
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015

Keywords provided by Dr. Gregor A. Stavrou, Asklepios Kliniken Hamburg GmbH:
Primovist MRI

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts