A Study on the Verification of Kidney CT Non-inferiority Using Low Concentration Contrast Agent
NCT ID: NCT05831943
Last Updated: 2023-04-26
Study Results
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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UNKNOWN
88 participants
OBSERVATIONAL
2023-01-20
2023-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Renal CT evaluation
Patients who are planned kidney contrast enhanced CT scan
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Those who understand the contents of the research subject explanation and voluntarily sign the consent form
Exclusion Criteria
* 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
19 Years
80 Years
ALL
Yes
Sponsors
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Taejoon Pharmaceutical Co., Ltd.
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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June Young Seo
Clinical fellow
Principal Investigators
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June Young Seo, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Jong-no Gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SNUH-2022-0218
Identifier Type: -
Identifier Source: org_study_id
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