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

Sponsor

Foothills Medical Centre (Other)

Overall Status

Completed

CT.gov ID

NCT00828607

Collaborator

Vancouver General Hospital (Other), London Health Sciences Centre (Other), Centre hospitalier de l'Université de Montréal (CHUM) (Other)

250

Enrollment

Locations

Duration (Months)

62.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Tumors

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

250 participants

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)

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
liver mass The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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