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Clinical Trials/NCT02283307
NCT02283307CompletedNot Applicable

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

University of Washington2 sites in 1 country62 target enrollmentStarted: September 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
2
Primary Endpoint
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

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Arms & Interventions

Reduced contrast DECT scan

Experimental

Reduced Contrast Dual Energy CT

Intervention: Reduced contrast DECT scan (Other)

Reduced contrast DECT scan

Experimental

Reduced Contrast Dual Energy CT

Intervention: Standard contrast SECT scan (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

William Shuman

Professor and Vice Chair of Radiology

University of Washington

Study Sites (2)

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