Renal Protocol Protection in CKD Patients

HCC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04024514
• Other study ID #: SNUH-2019-0343
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 24, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: September 30, 2023
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• CKD
• HCC

Intervention

Other:
• low dose CT contrast media
CT contrast media (Ioversol 320mgI/kg) is administrated at a dose of 300mgI/kg in low dose group
• Standard dose CT contrast media
CT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Contrast media (CM) dose	administered CM dose in each group	3 months after complete enrollment
Secondary	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
Secondary	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
Secondary	Lesion conspicuity	qualitative scoring for focal lesion depiction on five-point scale	12 months after complete enrollment
Secondary	lesion (HCC) detection	detection rate of focal liver lesion/HCC on CT	12 months after complete enrollment