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

This study is currently recruiting participants.
Verified January 2012 by Asklepios Kliniken Hamburg GmbH
Sponsor:
Information provided by (Responsible Party):
Dr. Gregor A. Stavrou, Asklepios Kliniken Hamburg GmbH
ClinicalTrials.gov Identifier:
NCT01522209
First received: January 3, 2012
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Colorectal 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)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asklepios Kliniken Hamburg GmbH:

Primary Outcome Measures:
  • Detection of Liver Metastasis during Operation [ Time Frame: During Operation ] [ Designated as safety issue: No ]
    Intraoperative Rate of Detection of Liver Metastasis compared to preoperative Imaging Analysis


Secondary Outcome Measures:
  • Comparison of Detection Rate for Liver Metastases of all imaging modalities [ Time Frame: 1 Week after Operation ] [ Designated as safety issue: No ]
  • Comparison of Sensitivity of all imaging modalities [ Time Frame: one Year ] [ Designated as safety issue: No ]
  • Comparison of Specicivity of all imaging modalities [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522209

Contacts
Contact: Gregor A Stavrou, Dr.med +49401818828333 g.stavrou@asklepios.com

Locations
Germany
Asklepios Hospital Barmbek Recruiting
Hamburg, Germany, 22291
Contact: Gregor A Stavrou, Dr.med     +49401818828333     g.stavrou@asklepios.com    
Contact: Karl J Oldhafer, Prof. Dr.med     +494018118822811     k.oldhafer@asklepios.com    
Principal Investigator: Gregor A Stavrou, Dr.med            
Sponsors and Collaborators
Asklepios Kliniken Hamburg GmbH
Investigators
Principal Investigator: Gregor A Stavrou, Dr.med Dpt. of General and Visceral Surgery, Asklepios Hospital Barmbek, Hamburg, Germany
  More Information

Publications:

Responsible Party: Dr. Gregor A. Stavrou, Principal Investigator, Asklepios Kliniken Hamburg GmbH
ClinicalTrials.gov Identifier: NCT01522209     History of Changes
Other Study ID Numbers: Asklepios
Study First Received: January 3, 2012
Last Updated: January 27, 2012
Health Authority: Germany: Hamburg, Ethics Commission

Keywords provided by Asklepios Kliniken Hamburg GmbH:
CRLM
Primovist MRI
CEIOUS

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

ClinicalTrials.gov processed this record on May 21, 2013