Clinical trial NCT00828607: Contrast Enhanced (CE) Ultrasound and CE Computed Tomography or CE Magnetic Resonance Imaging in Liver Masses
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Tumors
Keywords: Contrast Enhanced Ultrasound (CEUS)
Liver tumors
Hepatocellular carcinoma
Hemangioma
Focal Nodular Hyperplasia
Hepatic metastases
Lead sponsor: Foothills Medical Centre
Sponsor class: OTHER
Collaborators: name: Vancouver General Hospital
name: London Health Sciences Centre
name: Centre hospitalier de l'Université de Montréal (CHUM)
First posted: 2009-01-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient with an unknown liver mass

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.

Eligibility 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

Primary outcomes:
measure: Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.
timeFrame: 6-9 months
Secondary outcomes:
measure: Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Medical centre
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc
state: Quebec
Study officials:
affiliation: Foothills Medical Centre
name: Stephanie R Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: