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

NCT ID: NCT01855204

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Exposure to Medical Diagnostic Radiation

Keywords

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Computed Tomography, Spiral Urography Radiation dosage Contrast media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Reduced

Computed tomographic urography was done with the protocols of low voltage and low iodine concentration.

Group Type EXPERIMENTAL

Computed tomographic urography

Intervention Type RADIATION

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

Conventional

Computed tomographic urography was done with conventional protocols.

Group Type ACTIVE_COMPARATOR

Computed tomographic urography

Intervention Type RADIATION

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

Interventions

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Computed tomographic urography

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Yeon Cho

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Yeon Cho, Professor

Role: PRINCIPAL_INVESTIGATOR

Departement of Radiology, Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeong Yeon Cho, Professor

Role: CONTACT

Phone: 82-2-2072-3074

Email: [email protected]

Sang Youn Kim, Professor

Role: CONTACT

Phone: 82-2-2072-3321

Email: [email protected]

Facility Contacts

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Jeong Yeon Cho, Professor

Role: primary

Sang Youn Kim, Professor

Role: backup

Other Identifiers

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SeoulNUH-rad

Identifier Type: -

Identifier Source: org_study_id