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Thoracoabdominal Arortic CTA Study

Primary Purpose

Thoracic Aortic Aneurysm

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Isovue
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thoracic Aortic Aneurysm focused on measuring Suspected or confirmed, TAA, Computed tomography angiography, CTA, Contrast agent, Radiation dose, Thoracoabdominal aortic aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Isovue 300 75mL

Isovue 370 75mL

Isovue 370 60mL

Arm Description

Isovue 300 75mL injected 120 kVp 250 mAs

Isovue 370 75mL injected 100 kVp 240 mAs

Isovue 370 60mL injected 100 kVp 240 mAs

Outcomes

Primary Outcome Measures

Radiation Dose

Secondary Outcome Measures

Signal to Noise Ratio
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.
Hounsfield Unit Attenuation Values
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.
Variation in Contrast for the Entire Vascular System (coV)
The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.

Full Information

First Posted
October 23, 2014
Last Updated
March 22, 2017
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02291718
Brief Title
Thoracoabdominal Arortic CTA Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Aortic Aneurysm
Keywords
Suspected or confirmed, TAA, Computed tomography angiography, CTA, Contrast agent, Radiation dose, Thoracoabdominal aortic aneurysm

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isovue 300 75mL
Arm Type
Active Comparator
Arm Description
Isovue 300 75mL injected 120 kVp 250 mAs
Arm Title
Isovue 370 75mL
Arm Type
Active Comparator
Arm Description
Isovue 370 75mL injected 100 kVp 240 mAs
Arm Title
Isovue 370 60mL
Arm Type
Active Comparator
Arm Description
Isovue 370 60mL injected 100 kVp 240 mAs
Intervention Type
Drug
Intervention Name(s)
Isovue
Intervention Description
iodine contrast
Primary Outcome Measure Information:
Title
Radiation Dose
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Signal to Noise Ratio
Description
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.
Time Frame
30 minutes
Title
Hounsfield Unit Attenuation Values
Description
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.
Time Frame
30 minutes
Title
Variation in Contrast for the Entire Vascular System (coV)
Description
The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Thoracoabdominal Arortic CTA Study

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