Contrast Enhanced (CE) Ultrasound and CE Computed Tomography or CE Magnetic Resonance Imaging in Liver Masses
Conditions
Liver Tumors
Conditions: official terms
Liver Neoplasms
Conditions: Keywords
Contrast Enhanced Ultrasound (CEUS), Liver tumors, Hepatocellular carcinoma, Hemangioma, Focal Nodular Hyperplasia, Hepatic metastases
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
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
Locations
Vancouver General Hospital
Vancouver, British Columbia, Canada
Status: Recruiting
Contact: Alison Harris, MD - 604 875 4340 - Alison.Harris@vch.ca
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Status: Completed
Sunnybrook Medical centre
Toronto, Ontario, Canada
Status: Recruiting
Contact: Laurent Milot, MD - 416 180 6100 - laurentt.milot@sunnybrook.ca
Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc
Montréal, Quebec, Canada
Status: Completed
Start Date
January 2009
Completion Date
August 2016
Sponsors
Foothills Medical Centre
Source
Foothills Medical Centre
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page