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

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ClinicalTrials.gov Identifier: NCT00828607
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : February 8, 2018
Sponsor:
Collaborators:
Vancouver General Hospital
London Health Sciences Centre
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by (Responsible Party):
Stephanie R Wilson, MD, Foothills Medical Centre

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 Type : Observational
Actual 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
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

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



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 ]


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

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


Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5
Sunnybrook Medical centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc
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

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: February 8, 2018
Last Verified: February 2018

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