Dual Energy CT Urography With Reduced Iodinated Contrast

May 7, 2018 updated by: William Shuman, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Reduced contrast DECT scan
Reduced Contrast Dual Energy CT
Other: Reduced contrast DECT scan
Subjects will undergo a dual energy CT scan with reduced contrast
Other: Standard contrast SECT scan
Subjects will undergo standard of care single energy CT scan with a standard dose of contrast. (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

August 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (ESTIMATE)

November 5, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47637

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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