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

NCT ID: NCT01151566

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-12-31

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.

Detailed Description

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Renal Compromise

Those referred for CT scan with identified renal compromise necessitating use of no contrast agent

No interventions assigned to this group

Sensitivity to CT Contrast Agents

Those referred for CT scan with prior demonstration of contrast sensitivity requiring use of no contrast

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• CT scan performed with contrast agent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lantheus Medical Imaging

INDUSTRY

Sponsor Role: collaborator

Foothills Medical Centre

OTHER

Sponsor Role: lead

Responsible Party

Stephanie R Wilson, MD

Clinical Professor of Radiology University of Calgary

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie R Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Professor University of Calgary

Locations

Diagnostic Imaging Foothills Medical Centre

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

21982

Identifier Type: -

Identifier Source: org_study_id