Can Ultrasound Replace Computed Tomography (CT) Scan in Those Unable to Have Computed Tomography (CT) Contrast Agents

NCT01151566 | Completed

• 1 other identifier: 21982
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Computed tomography (CT) scan, performed with contrast enhancement, is one of the most commonly requested examinations in diagnostic imaging. In a patient with an elevated creatinine or an allergy to contrast agents, the scan may be performed without the benefit of contrast enhancement. Ultrasound (US), performed with contrast agent enhancement does not have any nephrotoxicity and may be performed on patients with CT contrast allergy. The investigators propose that US with Contrast enhanced ultrasound (CEUS) is superior to unenhanced CT scan in this population.

Conditions

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

Keywords

Ultrasound; Contrast enhanced Ultrasound (CEUS); Nephrotoxicity; CT contrast agents

Outcome Measures

Primary Outcomes (1)

• Demonstration of superiority of US with CEUS over nonenhanced CT scan (NECT) for observations and interpretation of findings

  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.

  January 31, 2011

Study Arms (2)

Renal Compromise

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

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred for unenhanced CT scan on the basis of renal compromise of CT contrast agent sensitivity will be eligible for recruitment for our study.

You may qualify if:

• unenhanced CT scan of abdomen
• known renal compromise
• known hypersensitivity to CT contrast agents

You may not qualify if:

• CT scan performed with contrast agent

Sponsors & Collaborators

• Foothills Medical Centre: lead
• Lantheus Medical Imaging: collaborator

Study Sites (1)

Diagnostic Imaging Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Study Officials

• Stephanie R Wilson, MD

  Clinical Professor University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Radiology University of Calgary

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 28, 2010
• Study Start: September 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 13, 2014

Record last verified: 2012-03

Locations

CA (1)