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

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Disease

Intervention / Treatment
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* Diagnostic Test: Contrast enhanced Kidney CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Renal CT evaluation<br>Patients who are planned kidney contrast enhanced CT scan | Diagnostic Test: Contrast enhanced Kidney CT<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnoses of focal lesion and inter-observer agreement | Detection by three individual radiologist and its inter-observer agreement | 6 months after the CT scan |