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Dual Energy CT Urography With Reduced Iodinated Contrast

Primary Purpose

Aortic Aneurysm

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Reduced contrast DECT scan

Standard contrast SECT scan

About this trial

This is an interventional diagnostic trial for Aortic Aneurysm

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Washington Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reduced contrast DECT scan

Arm Description

Reduced Contrast Dual Energy CT

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02283307

First Posted

October 9, 2014

Last Updated

May 7, 2018

Sponsor

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT02283307

Brief Title

Dual Energy CT Urography With Reduced Iodinated Contrast

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Aneurysm

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reduced contrast DECT scan

Arm Type

Experimental

Arm Description

Reduced Contrast Dual Energy CT

Intervention Type

Other

Intervention Name(s)

Reduced contrast DECT scan

Intervention Description

Subjects will undergo a dual energy CT scan with reduced contrast

Intervention Type

Other

Intervention Name(s)

Standard contrast SECT scan

Intervention Description

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Washington Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

12. IPD Sharing Statement

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Dual Energy CT Urography With Reduced Iodinated Contrast

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