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Completed

NCT Number: NCT02283307

Dual Energy CT Urography With Reduced Iodinated Contrast

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.

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Key information

Conditions

Aortic Aneurysm Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington Medical Center

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reduced contrast DECT scan

Other

Subjects will undergo a dual energy CT scan with reduced contrast

Standard contrast SECT scan

Other

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

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 5, 2014
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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