Exposure to Medical Diagnostic RadiationNCT01855204
Low Tube Voltage Computed Tomographic (CT) Urography Using Low Concentration Iodine Contrast Agent
A study testing Computed tomographic urography in people with Exposure to Medical Diagnostic Radiation, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Exposure to Medical Diagnostic Radiation
- What is being tested?
- Computed tomographic urography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Jeong Yeon Cho, Professor, 82-2-2072-3074, radjycho@snu.ac.kr
Sang Youn Kim, Professor, 82-2-2072-3321, iwishluv@empas.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Exposure to Medical Diagnostic Radiation
- Being tested
- Computed tomographic urography
- Keywords
- Computed Tomography, Spiral, Urography, Radiation dosage, Contrast media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomographic urographyRadiation
Computed tomographic (CT) urography was done with the protocols of low voltage and low iodine concentration.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Computed tomographic urography was done with conventional protocols. Receives: Radiation: Computed tomographic urography |
| Reduced | Experimental | Computed tomographic urography was done with the protocols of low voltage and low iodine concentration. Receives: Radiation: Computed tomographic urography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Radiation Dose
Measured: The day of admission (within 24hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure to Medical Diagnostic RadiationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Yeon Cho, Seoul National University Hospital
- Investigators
- Jeong Yeon Cho, Professor, Principal investigator, Departement of Radiology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855204
- Sponsor's protocol ID
- SeoulNUH-rad
- Status last verified
- Dec 2013
- First submitted
- 27 Apr 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Tube Voltage Computed Tomographic (CT) Urography Using Low Concentration Iodine Contrast Agent: a Comparison Study With Conventional CT Urography
- ClinicalTrials.gov ID
- NCT01855204
- Acronym / sponsor ID
- SeoulNUH-rad
- Conditions
- Exposure to Medical Diagnostic Radiation
- Keywords
- Computed Tomography, Spiral, Urography, Radiation dosage, Contrast media
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Radiation: Computed tomographic urographyComputed tomographic urography was done with conventional protocols. |
| Reduced | Experimental | Radiation: Computed tomographic urographyComputed tomographic urography was done with the protocols of low voltage and low iodine concentration. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomographic urographyComputed tomographic (CT) urography was done with the protocols of low voltage and low iodine concentration. | Radiation | Conventional, Reduced |
Primary outcome
Measurement of Radiation Dose
Time frame: The day of admission (within 24hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Yeon Cho, Professor principal investigator
Departement of Radiology, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed tomographic urography in people with Exposure to Medical Diagnostic Radiation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong Yeon Cho, Professor (82-2-2072-3074, radjycho@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Radiation Dose (time frame: The day of admission (within 24hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.