CKD, HCC
Conditions
Keywords
CT, Spectral
Brief summary
This study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low keV imaging in chronic kidney disease.
Interventions
OTHERlow dose CT contrast media
CT contrast media (Ioversol 320mgI/kg) is administrated at a dose of 300mgI/kg in low dose group
CT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall image quality | 6 months after complete enrollment | qualitative scoring for image quality on five-point scale (1: worst, 5: excellent, representative value is average score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast media (CM) dose | 3 months after complete enrollment | administered CM dose in each group |
| Incidence of Contrast media-induced nephrotoxicity | 3 days after contrast media administration | 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 |
| Image contrast | 12 months after complete enrollment | qualitative scoring for image contrast on five-point scale (1: worst, 5: excellent, representative value is average score) |
| Lesion conspicuity | 12 months after complete enrollment | qualitative scoring for focal lesion depiction on five-point scale |
| lesion (HCC) detection | 12 months after complete enrollment | detection rate of focal liver lesion/HCC on CT |
Countries
South Korea
Outcome results
None listed