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

Exposure to Medical Diagnostic Radiation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01855204
• Other study ID #: SeoulNUH-rad
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2013
• Last updated: December 3, 2013
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: Jeong Yeon Cho, Professor
• Phone: 82-2-2072-3074
• Email: radjycho[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Exposure to Medical Diagnostic Radiation

Intervention

Radiation:
• Computed tomographic urography
Computed tomographic (CT) urography was done with the protocols of low voltage and low iodine concentration.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Radiation Dose		The day of admission (within 24hours)	No