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CompletedNCT02283307Updated May 14, 2018

Dual Energy CT Urography With Reduced Iodinated Contrast

An interventional study of Reduced contrast DECT scan and Standard contrast SECT scan in Aortic Aneurysm, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-05-14.

Sponsored by University of Washington · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aortic Aneurysm

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03

In context

Aortic Aneurysm

663 studies on the registry are indexed under Aortic Aneurysm; 117 are open to participants now.

This study's enrollment of 62 is close to the median of 62 across 318 interventional studies indexed under Aortic Aneurysm.

Browse Aortic Aneurysm studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age >50
  • Outpatient scheduled to have a CT urography at the site

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Reduced contrast DECT scan

    Reduced Contrast Dual Energy CT

    Other: Reduced contrast DECT scan · Other: Standard contrast SECT scan

Interventions

  • OtherReduced contrast DECT scan

    Subjects will undergo a dual energy CT scan with reduced contrast

  • OtherStandard contrast SECT scan

    Subjects will undergo standard of care single energy CT scan with a standard dose of contrast. (control)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 24 months

07

Study locations

1 site
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02283307
Lead sponsor
University of Washington
Responsible party
William Shuman (Professor and Vice Chair of Radiology, University of Washington) — Principal investigator
First posted
Nov 5, 2014
Start date
Sep 2014
Primary completion
Aug 2017
Completion
Aug 2017
Last update
May 14, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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