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

Status

Completed

Conditions

Intervention / Treatment

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

  • United States
    • 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
Drug: Isovue
iodine contrast
Active Comparator: Isovue 370 75mL
Isovue 370 75mL injected 100 kVp 240 mAs
Drug: Isovue
iodine contrast
Active Comparator: Isovue 370 60mL
Isovue 370 60mL injected 100 kVp 240 mAs
Drug: Isovue
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

Duke University

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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