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

Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831943
• Other study ID #: SNUH-2022-0218
• Status: Recruiting
• Start date: January 20, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: June Young Seo, MD
• Phone: 82-2-2072-2518
• Email: razorwind4[@]naver.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: August 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Disease

Intervention

Diagnostic Test:
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jong-no Gu

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Taejoon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative analysis - Radiation dose	Effective radiation dose (mSv) annotated on CT image	6 months after the CT scan
Primary	Quantitative analysis - Signal to noise ratio	Value calculated by ( mean attenuation / standard deviation of attenuation of contrast area)	6 months after the CT scan
Primary	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
Primary	Qualitative analysis - Diagnostic acceptability, Noise , Artifacts , Sharpness	4 points scale quantitative analysis evaluated by three different radiologists	6 months after the CT scan
Secondary	Diagnoses of focal lesion and inter-observer agreement	Detection by three individual radiologist and its inter-observer agreement	6 months after the CT scan