Renal Protocol Protection in CKD Patients

Study Overview
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Brief Summary
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This study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low keV imaging in chronic kidney disease.

Official Title
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Development of Renal Protection Protocol Using Low Dose Contrast Media and Spectral Computed Tomography in Chronic Kidney Disease Patients

Conditions
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HCC, CKD

Intervention / Treatment
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* Other: low dose CT contrast media
* Other: Standard dose CT contrast media


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High risk group for developing HCC Scheduled contrast-enhanced CT for HCC diagnosis or surveillance chronic kidney disease (Estimated GFR < 60mL/min/1.73m2) Exclusion Criteria: not a high risk group for developing HCC congestive hepatopathy on dialysis no venous access on forearm anticipated beam hardening artifact due to prosthesis relative/absolute contra-indication of contrast-enhanced CT except CKD (Estimated GFR < 60mL/min/1.73m2)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br>Low CT contrast media dose | Other: low dose CT contrast media<br>* CT contrast media (Ioversol 320mgI/kg) is administrated at a dose of 300mgI/kg in low dose group<br>|
| Active Comparator: Standard dose<br>Standard CT contrast media dose | Other: Standard dose CT contrast media<br>* CT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall image quality | qualitative scoring for image quality on five-point scale (1: worst, 5: excellent, representative value is average score) | 6 months after complete enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast media (CM) dose | administered CM dose in each group | 3 months after complete enrollment | 
| Incidence of Contrast media-induced nephrotoxicity | serum Cr level increase by 25% or more of the baseline, or 0.5mg/dl in 3 days after contrast media administration without other cause | 3 days after contrast media administration | 
| Image contrast | qualitative scoring for image contrast on five-point scale (1: worst, 5: excellent, representative value is average score) | 12 months after complete enrollment | 
| Lesion conspicuity | qualitative scoring for focal lesion depiction on five-point scale | 12 months after complete enrollment | 
| lesion (HCC) detection | detection rate of focal liver lesion/HCC on CT | 12 months after complete enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT, Spectral