NCT04024514

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

December 24, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2020

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

July 17, 2019

Last Update Submit

March 30, 2023

Conditions

HCCCKD

Keywords

CTSpectral

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Contrast media (CM) dose

    3 months after complete enrollment

  • Incidence of Contrast media-induced nephrotoxicity

    3 days after contrast media administration

  • Image contrast

    12 months after complete enrollment

  • Lesion conspicuity

    12 months after complete enrollment

  • lesion (HCC) detection

    12 months after complete enrollment

Study Arms (2)

Low dose

EXPERIMENTAL

Low CT contrast media dose

Other: low dose CT contrast media

Standard dose

ACTIVE COMPARATOR

Standard CT contrast media dose

Other: Standard dose CT contrast media

Interventions

low dose CT contrast mediaOTHER

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

Low dose
Standard dose CT contrast mediaOTHER

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

Standard dose

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High risk group for developing HCC
  • Scheduled contrast-enhanced CT for HCC diagnosis or surveillance
  • chronic kidney disease (Estimated GFR \< 60mL/min/1.73m2)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 37858212DERIVED

Study Officials

  • Jeong Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 18, 2019

Study Start

December 24, 2019

Primary Completion

December 11, 2020

Study Completion

September 30, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)