HCCNCT04024514
Renal Protocol Protection in CKD Patients
A study testing low dose CT contrast media and Standard dose CT contrast media in people with HCC and CKD, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- What is being tested?
- low dose CT contrast media and Standard dose CT contrast media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Dec 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High risk group for developing HCC
- Scheduled contrast-enhanced CT for HCC diagnosis or surveillance
- chronic kidney disease (Estimated GFR < 60mL/min/1.73m2)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Renal Protection Protocol Using Low Dose Contrast Media and Spectral Computed Tomography in Chronic Kidney Disease Patients
This study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low keV imaging in chronic kidney disease.
- Being tested
- low dose CT contrast media, Standard dose CT contrast media
- Keywords
- CT, Spectral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose CT contrast mediaOther
CT contrast media (Ioversol 320mgI/kg) is administrated at a dose of 300mgI/kg in low dose group
Standard dose CT contrast mediaOther
CT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Low CT contrast media dose Receives: Other: low dose CT contrast media |
| Standard dose | Active comparator | Standard CT contrast media dose Receives: Other: Standard dose CT contrast media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall image quality
qualitative scoring for image quality on five-point scale (1: worst, 5: excellent, representative value is average score)
Measured: 6 months after complete enrollment
Secondary outcomes (5)
Contrast media (CM) dose
administered CM dose in each group
Measured: 3 months after complete enrollment
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
Measured: 3 days after contrast media administration
Image contrast
qualitative scoring for image contrast on five-point scale (1: worst, 5: excellent, representative value is average score)
Measured: 12 months after complete enrollment
Lesion conspicuity
qualitative scoring for focal lesion depiction on five-point scale
Measured: 12 months after complete enrollment
lesion (HCC) detection
detection rate of focal liver lesion/HCC on CT
Measured: 12 months after complete enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start24 Dec 2019
- Primary completion11 Dec 2020
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024514
- Sponsor's protocol ID
- SNUH-2019-0343
- Status last verified
- Mar 2023
- First submitted
- 17 Jul 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37858212
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Renal Protection Protocol Using Low Dose Contrast Media and Spectral Computed Tomography in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT04024514
- Acronym / sponsor ID
- SNUH-2019-0343
- Keywords
- CT, Spectral
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low keV imaging in chronic kidney disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Other: low dose CT contrast mediaLow CT contrast media dose |
| Standard dose | Active comparator | Other: Standard dose CT contrast mediaStandard CT contrast media dose |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- High risk group for developing HCC
- Scheduled contrast-enhanced CT for HCC diagnosis or surveillance
- chronic kidney disease (Estimated GFR < 60mL/min/1.73m2)
Key exclusion criteria (6 listed)
- not a high risk group for developing HCC
- congestive hepatopathy
- on dialysis
- no venous access on forearm
- anticipated beam hardening artifact due to prosthesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dose CT contrast mediaCT contrast media (Ioversol 320mgI/kg) is administrated at a dose of 300mgI/kg in low dose group | Other | Low dose |
| Standard dose CT contrast mediaCT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group. | Other | Standard dose |
Primary outcome
Overall image quality
Time frame: 6 months after complete enrollment
qualitative scoring for image quality on five-point scale (1: worst, 5: excellent, representative value is average score)
5 secondary outcomes
Contrast media (CM) dose
Time frame: 3 months after complete enrollment
Incidence of Contrast media-induced nephrotoxicity
Time frame: 3 days after contrast media administration
Image contrast
Time frame: 12 months after complete enrollment
Lesion conspicuity
Time frame: 12 months after complete enrollment
lesion (HCC) detection
Time frame: 12 months after complete enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 37858212Yoon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Min Lee, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low dose CT contrast media and Standard dose CT contrast media in people with HCC and CKD, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall image quality (time frame: 6 months after complete enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04024514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.