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

This study has been completed.
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
Stephanie R Wilson, MD, Foothills Medical Centre
ClinicalTrials.gov Identifier:
NCT01151566
First received: June 8, 2010
Last updated: March 11, 2014
Last verified: March 2012
  Purpose

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.


Condition
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can US With CEUS Replace the Nonenhanced CT Scan in Patients With Contraindication to CT Contrast Agent

Resource links provided by NLM:


Further study details as provided by Foothills Medical Centre:

Primary Outcome Measures:
  • Demonstration of superiority of US with CEUS over nonenhanced CT scan (NECT) for observations and interpretation of findings [ Time Frame: January 31, 2011 ] [ Designated as safety issue: No ]

    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.



Enrollment: 250
Study Start Date: September 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151566

Locations
Canada, Alberta
Diagnostic Imaging Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
Foothills Medical Centre
Lantheus Medical Imaging
Investigators
Principal Investigator: Stephanie R Wilson, MD Clinical Professor University of Calgary
  More Information

No publications provided

Responsible Party: Stephanie R Wilson, MD, Clinical Professor of Radiology University of Calgary, Foothills Medical Centre
ClinicalTrials.gov Identifier: NCT01151566     History of Changes
Other Study ID Numbers: 21982
Study First Received: June 8, 2010
Last Updated: March 11, 2014
Health Authority: Canada: Health Canada

Keywords provided by Foothills Medical Centre:
Ultrasound
Contrast enhanced Ultrasound (CEUS)
Nephrotoxicity
CT contrast agents

Additional relevant MeSH terms:
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014