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

NCT00828607 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2018-02-08

No results posted yet for this study

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.

Conditions

  • Liver Tumors

Sponsors & Collaborators

  • Vancouver General Hospital

    collaborator OTHER

  • London Health Sciences Centre

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    collaborator OTHER

  • Foothills Medical Centre

    lead OTHER

Principal Investigators

  • Stephanie R Wilson, MD · Foothills Medical Centre

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00828607 on ClinicalTrials.gov