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

Conditions

Liver Tumors

Keywords

Contrast Enhanced Ultrasound (CEUS), Liver tumors, Hepatocellular carcinoma, Hemangioma, Focal Nodular Hyperplasia, Hepatic metastases

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.

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.

Related papers

No related papers found yet.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results