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

Recruiting

• Conditions: Renal Disease
• Interventions: Diagnostic Test: Contrast enhanced Kidney CT

• Registration Number: NCT05831943
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-20
• Status Verified: 2023-04
• Study First Submitted: 2023-04-16
• Study First Submitted QC: 2023-04-16
• Last Update Submitted: 2023-04-16
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-06-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Renal CT evaluation	Contrast enhanced Kidney CT	Patients who are planned kidney contrast enhanced CT scan

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Diagnoses of focal lesion and inter-observer agreement	6 months after the CT scan	Detection by three individual radiologist and its inter-observer agreement

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jong-no Gu, Korea, Republic of