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

Liver Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828607
• Other study ID #: (Ethics ID: 21295)
• Status: Completed
• Phase: N/A
• First received: January 23, 2009
• Last updated: February 6, 2018
• Start date: January 2009
• Est. completion date: December 2016

Study information

• Verified date: February 2018
• Source: Foothills Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumors

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Canada	Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc	Montréal	Quebec
Canada	Sunnybrook Medical centre	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Foothills Medical Centre	Centre hospitalier de l'Université de Montréal (CHUM), London Health Sciences Centre, Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.		6-9 months
Secondary	Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI.		6-9 months