Can Ultrasound Replace Computed Tomography (CT) Scan in Those Unable to Have Computed Tomography (CT) Contrast Agents (CEUS_CT)
|ClinicalTrials.gov Identifier: NCT01151566|
Recruitment Status : Completed
First Posted : June 28, 2010
Last Update Posted : March 13, 2014
|Condition or disease|
|Nephrotoxicity of CT Contrast Agents CT Scans in Those With Renal Compromise Sensitivity to CT Contrast Agents US With CEUS as Replacement for Unenhanced CT Scan|
Contrast enhanced computed tomography (CT) is one of the most common investigations performed in any radiology department, used widely in evaluating pathology in any part of the body.
Historically, it is well known that the use of contrast agents for CT scans may result in nephropathy, or renal failure. Nephrotoxicity associated with the injection of CT contrast agents may occasionally occur in healthy individuals and more commonly in those with borderline renal function. If abnormal kidney function is known to exist in a patient sent for CT scan, the examination is performed without the valuable assistance of contrast enhancement. Further, if prior hypersensitivity to the contrast agent for CT scan is known, again, the scan will be performed without the use of contrast agent.
Ultrasound (US) performed conventionally in grayscale and with Doppler is able to evaluate most abdominal and pelvic organs and also provides vascular information related to large vessel blood flow. Contrast enhanced ultrasound (CEUS) provides more precise information on blood flow than is available with Doppler and has been shown to be comparable to CT scan in some circumstances. We believe that a comparison of conventional US, with CEUS, and unenhanced CT scan would clearly favor ultrasound for detection of soft tissue pathology on the basis of its inherent tissue contrast differentiation.
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||Can US With CEUS Replace the Nonenhanced CT Scan in Patients With Contraindication to CT Contrast Agent|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Those referred for CT scan with identified renal compromise necessitating use of no contrast agent
Sensitivity to CT Contrast Agents
Those referred for CT scan with prior demonstration of contrast sensitivity requiring use of no contrast
- Demonstration of superiority of US with CEUS over nonenhanced CT scan (NECT) for observations and interpretation of findings [ Time Frame: January 31, 2011 ]
Superiority of US over nonenhanced CT scan will be shown in a blind read by independent interpretation of each study by two experienced radiologists. All positive observations and interpretations will be documented. A comparison will be performed against a truth panel based on a compilation of the patient's entire clinical record and outcome.
We hypothesize CT will result in multiple indeterminate examinations, and that all solid organ pathology will be more optimally characterized on US with contrast enhancement than on CT. Multiple other observations will be equal between the two studies.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151566
|Diagnostic Imaging Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 2T9|
|Principal Investigator:||Stephanie R Wilson, MD||Clinical Professor University of Calgary|