- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02291718
Thoracoabdominal Arortic CTA Study
March 22, 2017 updated by: Duke University
Comparison of High Iodine Concentration Contrast Material (Isovue 370) vs Standard Protocol (Isovue 300) in Thoracoabdominal Aortic Computed Tomographic Angiography (CTA) for Radiation Dose Reduction
The purpose of this study is to compare the contrast agents and imaging techniques used for thoracoabdominal aortic imaging in CT.
Imaging parameters and contrast volume are changed and adjusted based on the contrast agent, since contrast agents have varying iodine concentrations.
If the contrast iodine concentration is higher, it may be possible to adjust the imaging parameters and lower the overall radiation dose to the patient.
Study Overview
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing thoracoabdominal aortic (TAA) CTA
- Able to provide informed consent
- Body Mass Index (BMI) equal to or less than 30
Exclusion Criteria:
- Creatinine greater than 2.0
- Allergy to contrast media
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Isovue 300 75mL
Isovue 300 75mL injected 120 kVp 250 mAs
|
iodine contrast
|
Active Comparator: Isovue 370 75mL
Isovue 370 75mL injected 100 kVp 240 mAs
|
iodine contrast
|
Active Comparator: Isovue 370 60mL
Isovue 370 60mL injected 100 kVp 240 mAs
|
iodine contrast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radiation Dose
Time Frame: 30 minutes
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Signal to Noise Ratio
Time Frame: 30 minutes
|
Calculated as the ratio of mean attenuation values divided by the standard deviation of attenuation values gathered using a circular region of interest in the thoracic aorta.
|
30 minutes
|
Hounsfield Unit Attenuation Values
Time Frame: 30 minutes
|
Grayscale values on CT scans are given as Hounsfield units.
These Hounsfield units reflect the attenuation of x-ray beams traversing the aortic lumen.
We will use Hounsfield units to assess whether the tool contrast agents achieve similar attenuation characteristics essential for diagnosing aortic abnormalities.
We will use circular regions of interest in the thoracic aorta to extract the Hounsfield unit measurements.
|
30 minutes
|
Variation in Contrast for the Entire Vascular System (coV)
Time Frame: 30 minutes
|
The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
October 23, 2014
First Submitted That Met QC Criteria
November 11, 2014
First Posted (Estimate)
November 14, 2014
Study Record Updates
Last Update Posted (Actual)
April 18, 2017
Last Update Submitted That Met QC Criteria
March 22, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00048275
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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