Renal DiseaseNCT05831943

A Study on the Verification of Kidney CT Non-inferiority Using Low Concentration Contrast Agent

An observational study of Renal Disease, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

This prospective study aims to evaluate clinical usefulness of low-voltage renal CT using low-concentration contrast agent and to compare with existing imaging techniques. Read more about this study

Who is it for?: Ages 19 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Renal Disease
What is being tested?: Contrast enhanced Kidney CT
How many people: 88 participants
Where: 1 siteSouth Korea
Study dates: 20 Jan 2023to 30 Aug 2023
How long will I take part?: 1 Year
Phase: Observational
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 19 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Patients who need contrast enhanced CT scan for anatomical evaluation of kidney

Who may be able to join

Subjects with no abnormalities in renal function (Serum creatinine < 1.4 mg/dl , GFR > 45mL/min/1.73 m2) in blood tests performed within one month
Those who understand the contents of the research subject explanation and voluntarily sign the consent form

Who cannot join

Body mass index > 30
Subjects whose renal function abnormality was confirmed in a blood test (Serum creatinine > 1.4 mg/dl , GFR < 45mL/min/1.73 m2) conducted within one month
Diabetic patients taking metformin
Those with a history of urinary tract obstruction
Those with a history of bladder, urinary tract, or kidney surgery that may affect the evaluation of the contrast agent in the renal parenchyma
Those whose anatomical deformities have been identified in previous images that may interfere with image analysis

Show all 11Show fewer

Those who know or have been reported to have a history of contrast agent side effects in previous CT scans
Those with a history of hypersensitivity or adverse reactions to iobrix (intravascular CT contrast) or iodine based agent
Those with severe thyroid disease
Pregnancy
Those who are judged unsuitable for clinical trials by the researcher for reasons such as having other severe diseases or being judged to have a high risk of adverse reactions to intravascular contrast agents

Trial locations and contacts

1 site in 1 country.

June Young Seo, MD contact

82-2-2072-2518

razorwind4@naver.com

South Korea1 site, 1 recruiting

Seoul National University Hospital
Seoul, Jong-no Gu, 03080
June Young Seo, MD, 82-2-2072-2518, razorwind4@naver.com
Recruiting

Other trials in South Korea

About this study

Official title: Low Tube Voltage Kidney Computed Tomography Using Low Concentration Iodine Contrast Agent: A Comparison Study With Conventional CT Protocol

This prospective study aims to evaluate clinical usefulness of low-voltage renal CT using low-concentration contrast agent and to compare with existing imaging techniques.

Conditions: Renal Disease
Being tested: Contrast enhanced Kidney CT
Medical subject headings: Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Contrast enhanced Kidney CTDiagnostic test
- Test group : Patient undergoing CT scan with 80kVP protocol and using low concentration intravascular contrast media ( Iobrix 270 mgl/MI , Taejoon pharm, Seoul, South Korea)
- Control group : Patient undergoing CT scan with 120kVP protocol and using high concentration intravascular contrast media ( Iobrix 320 mgl/MI , Taejoon pharm, Seoul, South Korea)

Study groups in NCT05831943
Study group	Role	What they receive
Renal CT evaluation		Patients who are planned kidney contrast enhanced CT scan Receives: Diagnostic Test: Contrast enhanced Kidney CT

What is being measured

The primary outcome is the main question the study is designed to answer.

Quantitative analysis - Radiation dose
Effective radiation dose (mSv) annotated on CT image
Measured: 6 months after the CT scan
Quantitative analysis - Signal to noise ratio
Value calculated by ( mean attenuation / standard deviation of attenuation of contrast area)
Measured: 6 months after the CT scan
Quantitative analysis - Contrast to noise ratio
Value calculated by [ ( mean attenuation - attenuation of contrast area) / standard deviation of attenuation of contrast area ]
Measured: 6 months after the CT scan
Qualitative analysis - Diagnostic acceptability, Noise , Artifacts , Sharpness
4 points scale quantitative analysis evaluated by three different radiologists
Measured: 6 months after the CT scan

Secondary outcomes (1)

Diagnoses of focal lesion and inter-observer agreement
Detection by three individual radiologist and its inter-observer agreement
Measured: 6 months after the CT scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 202330 Aug 2023

First posted26 Apr 2023
Study start20 Jan 2023
Primary completion30 Jun 2023 (estimated)
Study completion30 Aug 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Renal DiseaseStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 88 participants (estimated)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT05831943
Sponsor's protocol ID: SNUH-2022-0218
Status last verified: Apr 2023
First submitted: 16 Apr 2023
Last updated: 26 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Choi MH, Lee YJ, Jung SE. The Image Quality and Diagnostic Performance of CT with Low-Concentration Iodine Contrast (240 mg Iodine/mL) for the Abdominal Organs. Diagnostics (Basel). 2022 Mar 19;12(3):752. doi: 10.3390/diagnostics12030752.
PubMed 35328304
Yoo YJ, Choi IY, Yeom SK, Cha SH, Jung Y, Han HJ, Shim E. Evaluation of Abdominal CT Obtained Using a Deep Learning-Based Image Reconstruction Engine Compared with CT Using Adaptive Statistical Iterative Reconstruction. J Belg Soc Radiol. 2022 Apr 8;106(1):15. doi: 10.5334/jbsr.2638. eCollection 2022.
PubMed 35480337
Ichikawa S, Motosugi U, Shimizu T, Kromrey ML, Aikawa Y, Tamada D, Onishi H. Diagnostic performance and image quality of low-tube voltage and low-contrast medium dose protocol with hybrid iterative reconstruction for hepatic dynamic CT. Br J Radiol. 2021 Dec;94(1128):20210601. doi: 10.1259/bjr.20210601. Epub 2021 Sep 29.
PubMed 34586900
Kim SY, Cho JY, Lee J, Hwang SI, Moon MH, Lee EJ, Hong SS, Kim CK, Kim KA, Park SB, Sung DJ, Kim Y, Kim YM, Jung SI, Rha SE, Kim DW, Lee H, Shim Y, Hwang I, Woo S, Choi HJ. Low-Tube-Voltage CT Urography Using Low-Concentration-Iodine Contrast Media and Iterative Reconstruction: A Multi-Institutional Randomized Controlled Trial for Comparison with Conventional CT Urography. Korean J Radiol. 2018 Nov-Dec;19(6):1119-1129. doi: 10.3348/kjr.2018.19.6.1119. Epub 2018 Oct 18.
PubMed 30386143
Taguchi N, Oda S, Utsunomiya D, Funama Y, Nakaura T, Imuta M, Yamamura S, Yuki H, Kidoh M, Hirata K, Namimoto T, Hatemura M, Kai N, Yamashita Y. Using 80 kVp on a 320-row scanner for hepatic multiphasic CT reduces the contrast dose by 50 % in patients at risk for contrast-induced nephropathy. Eur Radiol. 2017 Feb;27(2):812-820. doi: 10.1007/s00330-016-4435-y. Epub 2016 May 30.
PubMed 27240454
Zhang H, Ma Y, Lyu J, Yang Y, Yuan W, Song Z. Low kV and Low Concentration Contrast Agent with Iterative Reconstruction of Computed Tomography (CT) Coronary Angiography: A Preliminary Study. Med Sci Monit. 2017 Oct 20;23:5005-5010. doi: 10.12659/msm.904251.
PubMed 29051477
Botsikas D, Barnaure I, Terraz S, Becker CD, Kalovidouri A, Montet X. Value of liver computed tomography with iodixanol 270, 80 kVp and iterative reconstruction. World J Radiol. 2016 Jul 28;8(7):693-9. doi: 10.4329/wjr.v8.i7.693.
PubMed 27551339
Park IK, Park J, Kim TH, Lee J, Han K, Oh C, Park CH. Non-inferior low-dose coronary computed tomography angiography image quality with knowledge-based iterative model reconstruction for overweight patients. PLoS One. 2018 Dec 26;13(12):e0209243. doi: 10.1371/journal.pone.0209243. eCollection 2018.
PubMed 30586449
Hwang I, Cho JY, Kim SY, Oh SJ, Ku JH, Lee J, Kim SH. Low tube voltage computed tomography urography using low-concentration contrast media: Comparison of image quality in conventional computed tomography urography. Eur J Radiol. 2015 Dec;84(12):2454-63. doi: 10.1016/j.ejrad.2015.09.010. Epub 2015 Sep 10.
PubMed 26388465
Mayer C, Meyer M, Fink C, Schmidt B, Sedlmair M, Schoenberg SO, Henzler T. Potential for radiation dose savings in abdominal and chest CT using automatic tube voltage selection in combination with automatic tube current modulation. AJR Am J Roentgenol. 2014 Aug;203(2):292-9. doi: 10.2214/AJR.13.11628.
PubMed 25055262
Araki K, Yoshizako T, Yoshida R, Tada K, Kitagaki H. Low-voltage (80-kVp) abdominopelvic computed tomography allows 60% contrast dose reduction in patients at risk of contrast-induced nephropathy. Clin Imaging. 2018 Sep-Oct;51:352-355. doi: 10.1016/j.clinimag.2018.05.027. Epub 2018 Jun 9.
PubMed 29982133

Want to know more?

June Young Seo, MD

82-2-2072-2518

razorwind4@naver.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low Tube Voltage Kidney Computed Tomography Using Low Concentration Iodine Contrast Agent: A Comparison Study With Conventional CT Protocol
ClinicalTrials.gov ID: NCT05831943
Acronym / sponsor ID: SNUH-2022-0218
Conditions: Renal Disease
Study type: Observational
Recruitment status: Unknown status
Enrolment: 88 participants (estimated)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Collaborators: Taejoon Pharmaceutical Co., Ltd.
Study start: 20 Jan 2023 (actual)
Primary completion: 30 Jun 2023 (estimated)
Study completion: 30 Aug 2023 (estimated)
First posted: 26 Apr 2023 (actual)
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.

This prospective study aims to evaluate clinical usefulness of low-voltage renal CT using low-concentration contrast agent and to compare with existing imaging techniques.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year
Number of arms: 1

Arm	Type	Receives
Renal CT evaluation	–	Diagnostic Test: Contrast enhanced Kidney CTPatients who are planned kidney contrast enhanced CT scan

Who may qualify

Ages: 19 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Patients who need contrast enhanced CT scan for anatomical evaluation of kidney

Key inclusion criteria (2 listed)

Subjects with no abnormalities in renal function (Serum creatinine < 1.4 mg/dl , GFR > 45mL/min/1.73 m2) in blood tests performed within one month
Those who understand the contents of the research subject explanation and voluntarily sign the consent form

Key exclusion criteria (11 listed)

Body mass index > 30
Subjects whose renal function abnormality was confirmed in a blood test (Serum creatinine > 1.4 mg/dl , GFR < 45mL/min/1.73 m2) conducted within one month
Diabetic patients taking metformin
Those with a history of urinary tract obstruction
Those with a history of bladder, urinary tract, or kidney surgery that may affect the evaluation of the contrast agent in the renal parenchyma

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
Contrast enhanced Kidney CT* Test group : Patient undergoing CT scan with 80kVP protocol and using low concentration intravascular contrast media ( Iobrix 270 mgl/MI , Taejoon pharm, Seoul, South Korea) * Control group : Patient undergoing CT scan with 120kVP protocol and using high concentration intravascular contrast media ( Iobrix 320 mgl/MI , Taejoon pharm, Seoul, South Korea)	Diagnostic test	Renal CT evaluation

Primary outcome

Quantitative analysis - Radiation dose
Time frame: 6 months after the CT scan
Effective radiation dose (mSv) annotated on CT image
Quantitative analysis - Signal to noise ratio
Time frame: 6 months after the CT scan
Value calculated by ( mean attenuation / standard deviation of attenuation of contrast area)
Quantitative analysis - Contrast to noise ratio
Time frame: 6 months after the CT scan
Value calculated by [ ( mean attenuation - attenuation of contrast area) / standard deviation of attenuation of contrast area ]
Qualitative analysis - Diagnostic acceptability, Noise , Artifacts , Sharpness
Time frame: 6 months after the CT scan
4 points scale quantitative analysis evaluated by three different radiologists

1 secondary outcome

Diagnoses of focal lesion and inter-observer agreement
Time frame: 6 months after the CT scan

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
Background: PubMed 35328304Choi MH, Lee YJ, Jung SE. The Image Quality and Diagnostic Performance of CT with Low-Concentration Iodine Contrast (240 mg Iodine/mL) for the Abdominal Organs. Diagnostics (Basel). 2022 Mar 19;12(3):752. doi: 10.3390/diagnostics12030752.
Background: PubMed 35480337Yoo YJ, Choi IY, Yeom SK, Cha SH, Jung Y, Han HJ, Shim E. Evaluation of Abdominal CT Obtained Using a Deep Learning-Based Image Reconstruction Engine Compared with CT Using Adaptive Statistical Iterative Reconstruction. J Belg Soc Radiol. 2022 Apr 8;106(1):15. doi: 10.5334/jbsr.2638. eCollection 2022.
Background: PubMed 34586900Ichikawa S, Motosugi U, Shimizu T, Kromrey ML, Aikawa Y, Tamada D, Onishi H. Diagnostic performance and image quality of low-tube voltage and low-contrast medium dose protocol with hybrid iterative reconstruction for hepatic dynamic CT. Br J Radiol. 2021 Dec;94(1128):20210601. doi: 10.1259/bjr.20210601. Epub 2021 Sep 29.
Background: PubMed 30386143Kim SY, Cho JY, Lee J, Hwang SI, Moon MH, Lee EJ, Hong SS, Kim CK, Kim KA, Park SB, Sung DJ, Kim Y, Kim YM, Jung SI, Rha SE, Kim DW, Lee H, Shim Y, Hwang I, Woo S, Choi HJ. Low-Tube-Voltage CT Urography Using Low-Concentration-Iodine Contrast Media and Iterative Reconstruction: A Multi-Institutional Randomized Controlled Trial for Comparison with Conventional CT Urography. Korean J Radiol. 2018 Nov-Dec;19(6):1119-1129. doi: 10.3348/kjr.2018.19.6.1119. Epub 2018 Oct 18.
Background: PubMed 27240454Taguchi N, Oda S, Utsunomiya D, Funama Y, Nakaura T, Imuta M, Yamamura S, Yuki H, Kidoh M, Hirata K, Namimoto T, Hatemura M, Kai N, Yamashita Y. Using 80 kVp on a 320-row scanner for hepatic multiphasic CT reduces the contrast dose by 50 % in patients at risk for contrast-induced nephropathy. Eur Radiol. 2017 Feb;27(2):812-820. doi: 10.1007/s00330-016-4435-y. Epub 2016 May 30.
Background: PubMed 29051477Zhang H, Ma Y, Lyu J, Yang Y, Yuan W, Song Z. Low kV and Low Concentration Contrast Agent with Iterative Reconstruction of Computed Tomography (CT) Coronary Angiography: A Preliminary Study. Med Sci Monit. 2017 Oct 20;23:5005-5010. doi: 10.12659/msm.904251.
Background: PubMed 27551339Botsikas D, Barnaure I, Terraz S, Becker CD, Kalovidouri A, Montet X. Value of liver computed tomography with iodixanol 270, 80 kVp and iterative reconstruction. World J Radiol. 2016 Jul 28;8(7):693-9. doi: 10.4329/wjr.v8.i7.693.
Background: PubMed 30586449Park IK, Park J, Kim TH, Lee J, Han K, Oh C, Park CH. Non-inferior low-dose coronary computed tomography angiography image quality with knowledge-based iterative model reconstruction for overweight patients. PLoS One. 2018 Dec 26;13(12):e0209243. doi: 10.1371/journal.pone.0209243. eCollection 2018.
Background: PubMed 26388465Hwang I, Cho JY, Kim SY, Oh SJ, Ku JH, Lee J, Kim SH. Low tube voltage computed tomography urography using low-concentration contrast media: Comparison of image quality in conventional computed tomography urography. Eur J Radiol. 2015 Dec;84(12):2454-63. doi: 10.1016/j.ejrad.2015.09.010. Epub 2015 Sep 10.
Background: PubMed 25055262Mayer C, Meyer M, Fink C, Schmidt B, Sedlmair M, Schoenberg SO, Henzler T. Potential for radiation dose savings in abdominal and chest CT using automatic tube voltage selection in combination with automatic tube current modulation. AJR Am J Roentgenol. 2014 Aug;203(2):292-9. doi: 10.2214/AJR.13.11628.
Background: PubMed 29982133Araki K, Yoshizako T, Yoshida R, Tada K, Kitagaki H. Low-voltage (80-kVp) abdominopelvic computed tomography allows 60% contrast dose reduction in patients at risk of contrast-induced nephropathy. Clin Imaging. 2018 Sep-Oct;51:352-355. doi: 10.1016/j.clinimag.2018.05.027. Epub 2018 Jun 9.
Individual participant dataSharing planned: No

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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.

June Young Seo, MD contact

82-2-2072-2518

razorwind4@naver.com

June Young Seo, MD principal investigator

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?

An observational study of Renal Disease, 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 11 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 26 Apr 2023. 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 June Young Seo, MD (82-2-2072-2518, razorwind4@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantitative analysis - Radiation dose (time frame: 6 months after the CT scan). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05831943, which also lists 11 linked publications.

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 26 Apr 2023.