Renal Disease
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTContrast 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)
Sponsors
Taejoon Pharmaceutical Co., Ltd.
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative analysis - Radiation dose | 6 months after the CT scan | Effective radiation dose (mSv) annotated on CT image |
| Quantitative analysis - Signal to noise ratio | 6 months after the CT scan | Value calculated by ( mean attenuation / standard deviation of attenuation of contrast area) |
| Quantitative analysis - Contrast to noise ratio | 6 months after the CT scan | Value calculated by \[ ( mean attenuation - attenuation of contrast area) / standard deviation of attenuation of contrast area \] |
| Qualitative analysis - Diagnostic acceptability, Noise , Artifacts , Sharpness | 6 months after the CT scan | 4 points scale quantitative analysis evaluated by three different radiologists |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnoses of focal lesion and inter-observer agreement | 6 months after the CT scan | Detection by three individual radiologist and its inter-observer agreement |
Countries
South Korea
Contacts
Primary ContactJune Young Seo, MD
Outcome results
None listed