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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Tumors

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| liver mass<br>The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast Enhanced Ultrasound (CEUS), Liver tumors, Hepatocellular carcinoma, Hemangioma, Focal Nodular Hyperplasia, Hepatic metastases