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

Characterization of Liver Masses With Contrast Enhanced Ultrasound (CEUS): A Comparison With Standard Institutional Contrast Enhanced CT (CECT) or MR Scan (CEMRI)

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 Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre, University Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Medical centre
  • Quebec
    • Montréal, Quebec, Canada, H2X 3J4
      • Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Any patient with an unknown liver mass

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.	6-9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.	6-9 months

Collaborators and Investigators

• Sponsor: Foothills Medical Centre
• Collaborators: Centre hospitalier de l'Université de Montréal (CHUM); London Health Sciences Centre; Vancouver General Hospital
• Investigators: Principal Investigator: Stephanie R Wilson, MD, Foothills Medical Centre

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: January 23, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (ESTIMATE): January 26, 2009

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Hepatocellular carcinoma; Hemangioma; Contrast Enhanced Ultrasound (CEUS); Hepatic metastases; Liver tumors; Focal Nodular Hyperplasia
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: (Ethics ID: 21295)