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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Foothills Medical Centre
Sponsor:
Collaborators:
Vancouver General Hospital
London Health Sciences Centre
Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Stephanie R Wilson, MD, Foothills Medical Centre
ClinicalTrials.gov Identifier:
NCT00828607
First received: January 23, 2009
Last updated: July 27, 2015
Last verified: July 2015
  Purpose

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
Liver Tumors

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Foothills Medical Centre:

Primary Outcome Measures:
  • Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI. [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI. [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2009
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
liver mass
The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Stephanie R Wilson, MD Foothills Medical Centre
  More Information

No publications provided

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)
Study First Received: January 23, 2009
Last Updated: July 27, 2015
Health Authority: Canada: Health Canada

Keywords provided by 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 Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2015