Low Tube Voltage Computed Tomographic (CT) Urography Using Low Concentration Iodine Contrast Agent

December 3, 2013 updated by: Jeong Yeon Cho, Seoul National University Hospital

Low Tube Voltage Computed Tomographic (CT) Urography Using Low Concentration Iodine Contrast Agent: a Comparison Study With Conventional CT Urography

Computed Tomographic (CT) urography is the best imaging modality to evaluate obstructing lesions of urinary tract such as urinary stone, tumor and inflammatory lesion. The purpose of our study is to compare images of CT urography performed by low voltage and low concentrated iodine CT contrast with them of conventional CT urography.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Computed Tomographic (CT) urography is the best imaging modality to evaluate obstructing lesions of urinary tract such as urinary stone, tumor and inflammatory lesion. It is needed that CT urography should have the high contrast between target lesion described as filling defect and adjacent contrast filled urinary tract. For the implementation of high contras, conventional CT urography has been performed with higher voltage and higher concentrated CT contrast than another CT protocols. The higher voltage results in the more radiation exposure. And the intravenous injection of higher concentrated CT contrast results in the increase of the prevalence of contrast induced nephrotoxicity.

The purpose of our study is to compare images of CT urography performed by low voltage and low concentrated iodine CT contrast with them of conventional CT urography.

Study Type

Interventional

Enrollment (Anticipated)

64

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 Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sang Youn Kim, Professor
        • Sub-Investigator:
          • JoongYub Lee, Professor

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients to perform Computed Tomographic (CT) urography
  • Patients without diminish of renal function (serum creatinine: more than 1.4 mg/dl & glomerular filtration rate: more than 34 mL/min/1.73 m2)

Exclusion Criteria:

  • patients to have operations and/or injuries of urinary system
  • patients to have the histories of anaphylaxis or allergic reaction about intravenous iodine contrast material

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional
Computed tomographic urography was done with conventional protocols.
Radiation: Computed tomographic urography
Computed tomographic (CT) urography was done with the protocols of low voltage and low iodine concentration.
Experimental: Reduced
Computed tomographic urography was done with the protocols of low voltage and low iodine concentration.
Radiation: Computed tomographic urography
Computed tomographic (CT) urography was done with the protocols of low voltage and low iodine concentration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of Radiation Dose
Time Frame: The day of admission (within 24hours)
The day of admission (within 24hours)

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jeong Yeon Cho, Professor, Departement of Radiology, Seoul National University Hospital

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

April 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

April 27, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 16, 2013

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SeoulNUH-rad

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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