Renal Protocol Protection in CKD Patients

NCT ID: NCT04024514

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-24

Study Completion Date

2023-09-30

Brief Summary

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This study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low keV imaging in chronic kidney disease.

Detailed Description

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Conditions

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HCC CKD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low dose

Low CT contrast media dose

Group Type EXPERIMENTAL

low dose CT contrast media

Intervention Type OTHER

CT contrast media (Ioversol 320mgI/kg) is administrated at a dose of 300mgI/kg in low dose group

Standard dose

Standard CT contrast media dose

Group Type ACTIVE_COMPARATOR

Standard dose CT contrast media

Intervention Type OTHER

CT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group.

Interventions

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low dose CT contrast media

CT contrast media (Ioversol 320mgI/kg) is administrated at a dose of 300mgI/kg in low dose group

Intervention Type OTHER

Standard dose CT contrast media

CT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Yoon JH, Park JY, Lee SM, Lee ES, Kim JH, Lee JM. Renal protection CT protocol using low-dose and low-concentration iodine contrast medium in at-risk patients of HCC and with chronic kidney disease: a randomized controlled non-inferiority trial. Cancer Imaging. 2023 Oct 19;23(1):100. doi: 10.1186/s40644-023-00616-0.

Reference Type DERIVED
PMID: 37858212 (View on PubMed)

Other Identifiers

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SNUH-2019-0343

Identifier Type: -

Identifier Source: org_study_id

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