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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02283307
Other study ID # 47637
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date August 2017

Study information

Verified date May 2018
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Reduced contrast DECT scan
Subjects will undergo a dual energy CT scan with reduced contrast
Standard contrast SECT scan
Subjects will undergo standard of care single energy CT scan with a standard dose of contrast. (control)

Locations

Country Name City State
United States University of Washington Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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