A Comparison of Contrast Enhanced Ultrasound (CEUS) and Contrast Enhanced Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) for Characterization of Focal Liver Masses
This study is currently recruiting participants.
Verified March 2012 by Foothills Medical Centre
Sponsor:
Foothills Medical Centre
Collaborators:
Vancouver General Hospital
London Health Sciences Centre
Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Stephanie R Wilson, MD, Foothills Medical Centre
ClinicalTrials.gov Identifier:
NCT00828607
First received: January 23, 2009
Last updated: March 1, 2012
Last verified: March 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 23, 2009 | ||||||||
| Last Updated Date | March 1, 2012 | ||||||||
| Start Date ICMJE | January 2009 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI. [ Time Frame: 6-9 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00828607 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI. [ Time Frame: 6-9 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Comparison of Contrast Enhanced Ultrasound (CEUS) and Contrast Enhanced Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) for Characterization of Focal Liver Masses | ||||||||
| Official Title ICMJE | Characterization of Liver Masses With Contrast Enhanced Ultrasound (CEUS): A Comparison With Standard Institutional Contrast Enhanced CT (CECT) or MR Scan (CEMRI) | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Any patient with an unknown liver mass |
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| Condition ICMJE | Liver Tumors | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | liver mass
The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging. |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 250 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00828607 | ||||||||
| Other Study ID Numbers ICMJE | (Ethics ID: 21295) | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Stephanie R Wilson, MD, Foothills Medical Centre | ||||||||
| Study Sponsor ICMJE | Foothills Medical Centre | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Foothills Medical Centre | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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