Dual Energy CT Urography With Reduced Iodinated Contrast

Aortic Aneurysm Clinical Trial

Official title:

Dual Energy CT Urography Using 50% Reduction in Iodinated Contrast: Feasibility, Image Quality, and Radiation Dose Reduction With Virtual Unenhanced Images.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283307
• Other study ID #: 47637
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: August 2017

Study information

• Verified date: May 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to validate that Dual Energy CT (DECT) urography when performed with a 50% reduction in iodinated contrast dose results in a CT exam with equal or better image quality and equal or better diagnostic capability compared to traditional Single Energy CT (SECT) performed with a standard contrast dose.

Description:

The investigators hypothesize that DECT urography performed with a 50% iodine dose reduction is equivalent to SECT urography performed with a full iodine dose for:

• Enhancement of the aorta, renal arteries, and renal veins

• Enhancement of the renal cortex

• Enhancement of the renal pelvis, ureters, and bladder

• Subjective evaluation of image quality

• Objective evaluation of image quality

In addition, the investigators hypothesize that DECT virtual non-contrast images using material suppression from the same low iodine CT exam results in equivalent diagnostic information compared to SECT true non-contrast images obtained in the same patient during the same exam. If the true non-contrast images could be replaced by the virtual non-contrast images without loss of information, there is potential for DECT to both significantly lower radiation dose as well as significantly decreasing iodine dose.

The investigators designed this research protocol to prospectively test these hypotheses in a population scanned with a 50% reduced iodine DECT urography protocol compared to a control population scanned with a standard iodine dose clinical SECT urography protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age >50

• Outpatient scheduled to have a CT urography at the site

Exclusion Criteria:

• Severe allergy to iodine containing contrast

• Pregnancy (which is very unlikely for those over 50)

• Body mass index (BMI) over 35 kg/m2

• Inability to provide informed consent

• Inpatient

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

Other:
• Reduced contrast DECT scan
Subjects will undergo a dual energy CT scan with reduced contrast
• Standard contrast SECT scan
Subjects will undergo standard of care single energy CT scan with a standard dose of contrast. (control)

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic ability determined by image quality (subjective and objective evaluation of vessel attenuation and depiction, image noise, image quality and information from virtual non-contrast		Up to 24 months