Dual Energy CT Urography With Reduced Iodinated Contrast

NCT ID: NCT02283307

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-08-31

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.

Conditions

Aortic Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Reduced contrast DECT scan

Reduced Contrast Dual Energy CT

Group Type: EXPERIMENTAL

Reduced contrast DECT scan

Intervention Type: OTHER

Subjects will undergo a dual energy CT scan with reduced contrast

Standard contrast SECT scan

Intervention Type: OTHER

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

Interventions

Reduced contrast DECT scan

Subjects will undergo a dual energy CT scan with reduced contrast

Intervention Type: OTHER

Standard contrast SECT scan

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

William Shuman

Professor and Vice Chair of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

47637

Identifier Type: -

Identifier Source: org_study_id