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 ongoing, but not recruiting participants.

First Received: January 23, 2009 No Changes Posted

Sponsors and Collaborators:	Foothills Medical Centre Vancouver General Hospital London Health Sciences Centre Centre Hospitalier de l'Université de Montréal
Information provided by:	Foothills Medical Centre
ClinicalTrials.gov Identifier:	NCT00828607

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:	Cohort, 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:

MedlinePlus related topics: Cancer Liver Cancer Nuclear Scans Ultrasound

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	250
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (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

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:	Foothills Medical Centre
Study ID Numbers:	(Ethics ID: 21295)
Study First Received:	January 23, 2009
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00828607 History of Changes
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

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Hyperplasia
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular

Hemangioma
Neoplasm Metastasis
Gastrointestinal Neoplasms
Hepatocellular Carcinoma
Carcinoma

Additional relevant MeSH terms:

Liver Neoplasms
Liver Diseases
Neoplasms

Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009