NCT05831943

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

April 16, 2023

Last Update Submit

April 16, 2023

Conditions

Renal Disease

Outcome Measures

Primary Outcomes (4)

  • Quantitative analysis - Radiation dose

    Effective radiation dose (mSv) annotated on CT image

    6 months after the CT scan

  • Quantitative analysis - Signal to noise ratio

    Value calculated by ( mean attenuation / standard deviation of attenuation of contrast area)

    6 months after the CT scan

  • Quantitative analysis - Contrast to noise ratio

    Value calculated by \[ ( mean attenuation - attenuation of contrast area) / standard deviation of attenuation of contrast area \]

    6 months after the CT scan

  • Qualitative analysis - Diagnostic acceptability, Noise , Artifacts , Sharpness

    4 points scale quantitative analysis evaluated by three different radiologists

    6 months after the CT scan

Secondary Outcomes (1)

  • Diagnoses of focal lesion and inter-observer agreement

    6 months after the CT scan

Study Arms (1)

Renal CT evaluation

Patients who are planned kidney contrast enhanced CT scan

Diagnostic Test: Contrast enhanced Kidney CT

Interventions

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)

Renal CT evaluation

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jong-no Gu, 03080, South Korea

RECRUITING

Related Publications (11)

  • 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.

    PMID: 35328304BACKGROUND

  • 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.

    PMID: 35480337BACKGROUND

  • 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.

    PMID: 34586900BACKGROUND

  • 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.

    PMID: 30386143BACKGROUND

  • 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.

    PMID: 27240454BACKGROUND

  • 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.

    PMID: 29051477BACKGROUND

  • 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.

    PMID: 27551339BACKGROUND

  • 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.

    PMID: 30586449BACKGROUND

  • 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.

    PMID: 26388465BACKGROUND

  • 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.

    PMID: 25055262BACKGROUND

  • 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.

    PMID: 29982133BACKGROUND

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • June Young Seo, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

June Young Seo, MD

CONTACT

82-2-2072-2518razorwind4@naver.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical fellow

Study Record Dates

First Submitted

April 16, 2023

First Posted

April 26, 2023

Study Start

January 20, 2023

Primary Completion

June 30, 2023

Study Completion

August 30, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)