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Trial record 38 of 38 for:    focused ultrasound | met

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00828607
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : February 8, 2018
Sponsor:
Collaborators:
Vancouver General Hospital
London Health Sciences Centre
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by (Responsible Party):
Stephanie R Wilson, MD, Foothills Medical Centre

Tracking Information
First Submitted Date January 23, 2009
First Posted Date January 26, 2009
Last Update Posted Date February 8, 2018
Study Start Date January 2009
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2009)
Malignancy of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI. [ Time Frame: 6-9 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00828607 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 23, 2009)
Diagnosis of the liver mass, as determined on US, on CEUS, and on CECT or CEMRI. [ Time Frame: 6-9 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Contrast Enhanced (CE) Ultrasound and CE Computed Tomography or CE Magnetic Resonance Imaging in Liver Masses
Official Title 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Any patient with an unknown liver mass
Condition Liver Tumors
Intervention Not Provided
Study Groups/Cohorts liver mass
The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 23, 2009)
250
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00828607
Other Study ID Numbers (Ethics ID: 21295)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stephanie R Wilson, MD, Foothills Medical Centre
Study Sponsor Foothills Medical Centre
Collaborators
  • Vancouver General Hospital
  • London Health Sciences Centre
  • Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Stephanie R Wilson, MD Foothills Medical Centre
PRS Account Foothills Medical Centre
Verification Date February 2018