Clinical trial NCT05831943: A Study on the Verification of Kidney CT Non-inferiority Using Low Concentration Contrast Agent
Official title: Low Tube Voltage Kidney Computed Tomography Using Low Concentration Iodine Contrast Agent: A Comparison Study With Conventional CT Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Taejoon Pharmaceutical Co., Ltd.
First posted: 2023-04-26
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who need contrast enhanced CT scan for anatomical evaluation of kidney

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quantitative analysis - Radiation dose
timeFrame: 6 months after the CT scan
measure: Quantitative analysis - Signal to noise ratio
timeFrame: 6 months after the CT scan
measure: Quantitative analysis - Contrast to noise ratio
timeFrame: 6 months after the CT scan
measure: Qualitative analysis - Diagnostic acceptability, Noise , Artifacts , Sharpness
timeFrame: 6 months after the CT scan
Secondary outcomes:
measure: Diagnoses of focal lesion and inter-observer agreement
timeFrame: 6 months after the CT scan
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jong-no Gu
Study officials:
affiliation: Seoul National University Hospital
name: June Young Seo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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