Thoracoabdominal Arortic CTA Study

Thoracic Aortic Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291718
• Other study ID #: Pro00048275
• Status: Completed
• Phase: Phase 4
• First received: October 23, 2014
• Last updated: September 18, 2015
• Start date: January 2014

Study information

• Verified date: September 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Thoracic Aortic Aneurysm

Intervention

Drug:
• Isovue
iodine contrast

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation dose		30 minutes	No
Secondary	Noise	The noise is assessed as standard deviation of attenuation values gathered using a circular region of interest in the thoracic aorta. Noise will be reported using Hounsfield units.	30 minutes	No
Secondary	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.	30 minutes	No
Secondary	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.	30 minutes	No
Secondary	Contrast to noise ratio		30 minutes	No