Dual Energy CT Urography With Reduced Iodinated Contrast

Not Applicable

Completed

• Conditions: Aortic Aneurysm
• Interventions: Other: Reduced contrast DECT scan; Other: Standard contrast SECT scan

• Registration Number: NCT02283307
• Lead Sponsor: University of Washington

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-05
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reduced contrast DECT scan	Standard contrast SECT scan	Reduced Contrast Dual Energy CT
Reduced contrast DECT scan	Reduced contrast DECT scan	Reduced Contrast Dual Energy CT

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States