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

Completed

• Conditions: Liver Tumors

• Registration Number: NCT00828607
• Lead Sponsor: Foothills Medical Centre

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-26
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

London Health Sciences Centre, University Hospital; 🇨🇦 London, Ontario, Canada

Sunnybrook Medical centre; 🇨🇦 Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc; 🇨🇦 Montréal, Quebec, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada