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
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Purpose
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.
| Condition |
|---|
|
Liver Tumors |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Characterization of Liver Masses With Contrast Enhanced Ultrasound (CEUS): A Comparison With Standard Institutional Contrast Enhanced CT (CECT) or MR Scan (CEMRI) |
Resource links provided by NLM:
Further study details as provided by Foothills Medical Centre:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
liver mass
The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging.
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Any patient with an unknown liver mass
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828607
Contacts
| Contact: Stephanie R Wilson, MD | 403 944 2680 | stephanie.wilson@albertahealthservices.ca |
| Contact: Sharron Martel | 403 944 2116 | sharron.martel@albertahealthservices.ca |
Locations
| Canada, British Columbia | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Alison Harris, MD 604 875 4340 Alison.Harris@vch.ca | |
| Sub-Investigator: Alison Harris, MD | |
| Canada, Ontario | |
| London Health Sciences Centre, University Hospital | Recruiting |
| London, Ontario, Canada, N6A 5A5 | |
| Contact: Cesare Romagnoli, MD 519-685-8500 ext 32333 Cesare.Romagnoli@LHSC.ON.CA | |
| Contact: Lisa Hagerty 519-685-8500 ext 32333 lisa.hagerty@lhsc.on.ca | |
| Sub-Investigator: Cesare Romagnoli, MD | |
| Sunnybrook Medical centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Laurent Milot, MD 416 180 6100 ext 7418 laurentt.milot@sunnybrook.ca | |
| Sub-Investigator: Laurent Milot, MD | |
| Canada, Quebec | |
| Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc | Recruiting |
| Montréal, Quebec, Canada, H2X 3J4 | |
| Contact: Jessica Murphy-Lavallee, MD (514) 890-8350 ext 3-5616 j_murphylavallee@hotmail.com | |
| Contact: Christelle Poupard 514 890-8350 ext 3-5616 | |
| Sub-Investigator: Jessica Murphy-Lavallee, MD | |
Sponsors and Collaborators
Foothills Medical Centre
Vancouver General Hospital
London Health Sciences Centre
Centre Hospitalier de l'Université de Montréal
Investigators
| Principal Investigator: | Stephanie R Wilson, MD | Foothills Medical Centre |
More Information
No publications provided
| Responsible Party: | Stephanie R Wilson, MD, Clinical Professor University of Calgary, Foothills Medical Centre |
| ClinicalTrials.gov Identifier: | NCT00828607 History of Changes |
| Other Study ID Numbers: | (Ethics ID: 21295) |
| Study First Received: | January 23, 2009 |
| Last Updated: | March 1, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Foothills Medical Centre:
|
Contrast Enhanced Ultrasound (CEUS) Liver tumors Hepatocellular carcinoma |
Hemangioma Focal Nodular Hyperplasia Hepatic metastases |
Additional relevant MeSH terms:
|
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 16, 2013