Nephrotoxicity of CT Contrast AgentsCEUS_CTNCT01151566
Can Ultrasound Replace Computed Tomography (CT) Scan in Those Unable to Have Computed Tomography (CT) Contrast Agents
An observational study of Nephrotoxicity of CT Contrast Agents and CT Scans in Those With Renal Compromise, run by Foothills Medical Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Nephrotoxicity of CT Contrast Agents, CT Scans in Those With Renal Compromise, Sensitivity to CT Contrast Agents
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- unenhanced CT scan of abdomen
- known renal compromise
- known hypersensitivity to CT contrast agents
Who cannot join
- CT scan performed with contrast agent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Diagnostic Imaging Foothills Medical Centre
Calgary, Alberta, T2N 2T9
About this study
Official title: Can US With CEUS Replace the Nonenhanced CT Scan in Patients With Contraindication to CT Contrast Agent
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.
Read the 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
- Keywords
- Ultrasound, Contrast enhanced Ultrasound (CEUS), Nephrotoxicity, CT contrast agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 31, 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotoxicity of CT Contrast AgentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foothills Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Responsible party
- Principal investigator, Stephanie R Wilson, MD, Foothills Medical Centre
- Investigators
- Stephanie R Wilson, MD, Principal investigator, Clinical Professor University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151566
- Sponsor's protocol ID
- 21982
- Acronym
- CEUS_CT
- Status last verified
- Mar 2012
- First submitted
- 8 Jun 2010
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can US With CEUS Replace the Nonenhanced CT Scan in Patients With Contraindication to CT Contrast Agent
- ClinicalTrials.gov ID
- NCT01151566
- Acronym / sponsor ID
- CEUS_CT / 21982
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Foothills Medical CentreUniversity, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Study start
- Sep 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- unenhanced CT scan of abdomen
- known renal compromise
- known hypersensitivity to CT contrast agents
Key exclusion criteria (1 listed)
- CT scan performed with contrast agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
Related trials for Nephrotoxicity of CT Contrast Agents
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie R Wilson, MD principal investigator
Clinical Professor University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotoxicity of CT Contrast Agents and CT Scans in Those With Renal Compromise, run by Foothills Medical Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of superiority of US with CEUS over nonenhanced CT scan (NECT) for observations and interpretation of findings (time frame: January 31, 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.