NCT02283307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

2.9 years

First QC Date

October 9, 2014

Last Update Submit

May 7, 2018

Conditions

Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Reduced contrast DECT scan

EXPERIMENTAL

Reduced Contrast Dual Energy CT

Other: Reduced contrast DECT scanOther: Standard contrast SECT scan

Interventions

Reduced contrast DECT scanOTHER

Subjects will undergo a dual energy CT scan with reduced contrast

Reduced contrast DECT scan
Standard contrast SECT scanOTHER

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

Reduced contrast DECT scan

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>50
  • Outpatient scheduled to have a CT urography at the site

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chair of Radiology

Study Record Dates

First Submitted

October 9, 2014

First Posted

November 5, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

US(1)