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Contrast Enhanced (CE) Ultrasound and CE Computed Tomography or CE Magnetic Resonance Imaging in Liver Masses

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.
ClinicalTrials.gov Identifier: NCT00828607
Recruitment Status : Unknown
Verified July 2015 by Stephanie R Wilson, MD, Foothills Medical Centre.
Recruitment status was:  Recruiting
First Posted : January 26, 2009
Last Update Posted : July 28, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Subjects with a focal liver mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed on standard ultrasound scanners with contrast specific imaging capability. The contrast agent used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the standard of care in the institution. Anonymized image files from all imaging will be shown independently to two readers, blinded to all clinical and demographic data, who will predict malignancy and diagnosis.

Condition or disease
Liver Tumors

Detailed Description:
This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Subjects with a focal liver mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed on standard ultrasound scanners with contrast specific imaging capability. The contrast agent used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the standard of care in the institution. Anonymized image files from all imaging will be shown independently to two readers, blinded to all clinical and demographic data, who will predict malignancy and diagnosis.

Study Design

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Liver Masses With Contrast Enhanced Ultrasound (CEUS): A Comparison With Standard Institutional Contrast Enhanced CT (CECT) or MR Scan (CEMRI)
Study Start Date : January 2009
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
liver mass
The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging.


Outcome Measures

Primary Outcome Measures :
  1. Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI. [ Time Frame: 6-9 months ]

Secondary Outcome Measures :
  1. Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI. [ Time Frame: 6-9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patient with an unknown liver mass
Criteria

Inclusion Criteria:

  • An incidental liver mass amenable to US evaluation
  • Undiagnosed liver mass
  • Mass threshold size is 2.5 cm
  • Source of subjects:

    • Liver mass found on conventional institutional US
    • Liver mass detected on CT and MRI that remain uncategorized
    • Referral of patient with a liver mass following detection in outside institution.
  • Confirmatory CT or MRI performed within 60 days of initial scan according to the institutional protocols

Exclusion Criteria:

  • Any known pre existing mass
  • Pregnancy
  • Severe or unstable cardiac disease, including angina, congestive heart failure, or arrhythmias
  • Severe COPD
  • Pulmonary hypertension
  • Bidirectional shunts
  • Transient right to left shunts
  • Known hypersensitivity to Definity or any of its components
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00828607


Contacts
Contact: Stephanie R Wilson, MD 403 944 2680 stephanie.wilson@albertahealthservices.ca
Contact: Faye Cortezano 403 944 2116 faye.cortezano@albertahealthservices.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Alison Harris, MD    604 875 4340    Alison.Harris@vch.ca   
Sub-Investigator: Alison Harris, MD         
Canada, Ontario
London Health Sciences Centre, University Hospital Completed
London, Ontario, Canada, N6A 5A5
Sunnybrook Medical centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Laurent Milot, MD    416 180 6100 ext 7418    laurentt.milot@sunnybrook.ca   
Sub-Investigator: Laurent Milot, MD         
Canada, Quebec
Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc Completed
Montréal, Quebec, Canada, H2X 3J4
Sponsors and Collaborators
Foothills Medical Centre
Vancouver General Hospital
London Health Sciences Centre
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Stephanie R Wilson, MD Foothills Medical Centre
More Information

Responsible Party: Stephanie R Wilson, MD, Clinical Professor University of Calgary, Foothills Medical Centre
ClinicalTrials.gov Identifier: NCT00828607     History of Changes
Other Study ID Numbers: (Ethics ID: 21295)
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Stephanie R Wilson, MD, Foothills Medical Centre:
Contrast Enhanced Ultrasound (CEUS)
Liver tumors
Hepatocellular carcinoma
Hemangioma
Focal Nodular Hyperplasia
Hepatic metastases

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases