Hepatocellular CarcinomaNCT04722120
Low Contrast Agent and Radiation Dose Protocol for Liver CT in Patients With HCC
A study testing Low radiation dose CT, Conventional CT (radiation) and Low contrast dose CT in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the image quality and clinical feasibility of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Low radiation dose CT, Conventional CT (radiation) and Low contrast dose CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2016to 1 Jan 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver cirrhosis
- Tumor marker (aFP, PIVKA) elevation
- Nodular lesion on USG
- Received RFA for HCC
Who cannot join
- hypersensitivity at iodine
- GFR under 30
- BMI over 30
- Nursing or pregnant women
- enrolled the other study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Contrast Agent and Radiation Dose Protocol Liver CT With Deep-learning-based Contrast Boosting Model in Patients at High Risk for HCC: Prospective, Randomized, Single Blinded - Preliminary Study
The purpose of this study is to investigate the image quality and clinical feasibility of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.
Read the detailed description
The purpose of this study is to investigate the image quality (CNR, subjective inage quality, vessel and lesion conspicuity) and clinical feasibility (rate of lesion detection) of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Low radiation dose CT, Conventional CT (radiation), Low contrast dose CT, Conventional CT (contrast agent), Deep-learning based contrast boosting algorithms
- Keywords
- CT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low radiation dose CTRadiation
Underwent liver CT with 30% lower radiation dose
Conventional CT (radiation)Radiation
Underwent liver CT without change of radiation.
Low contrast dose CTDrug
Also called Low contrast medium dosage
Underwent liver CT 20% lower dose contrast media.
Conventional CT (contrast agent)Drug
Also called Standard contrast medium dosage
Underwent liver CT without change of contrast media doses.
Deep-learning based contrast boosting algorithmsOther
Applied deep-learning based contrast boosting algorithms on acquired CT images
| Study group | Role | What they receive |
|---|---|---|
| Conventional liver CT | Active comparator | Underwent conventional liver CT on HCC high-risk patient Receives: Radiation: Conventional CT (radiation); Drug: Conventional CT (contrast agent) |
| Double low dose CT | Experimental | Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient Receives: Radiation: Low radiation dose CT; Drug: Low contrast dose CT; Other: Deep-learning based contrast boosting algorithms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of solid focal lesion in liver
diagnostic performance
Measured: 12 months after last patient's image work up
Quantitative image quality analysis
Contrast-to-Noise
Measured: Immediate after study enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Jun 2016
- Primary completion1 Jan 2018
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 68 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
- NCT04722120
- Sponsor's protocol ID
- SNUH-2016-2272
- Status last verified
- Jan 2022
- First submitted
- 8 Sep 2016
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Contrast Agent and Radiation Dose Protocol Liver CT With Deep-learning-based Contrast Boosting Model in Patients at High Risk for HCC: Prospective, Randomized, Single Blinded - Preliminary Study
- ClinicalTrials.gov ID
- NCT04722120
- Acronym / sponsor ID
- SNUH-2016-2272
- Conditions
- Hepatocellular Carcinoma
- Keywords
- CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 25 Jan 2021 (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.
The purpose of this study is to investigate the image quality and clinical feasibility of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.
Detailed description
The purpose of this study is to investigate the image quality (CNR, subjective inage quality, vessel and lesion conspicuity) and clinical feasibility (rate of lesion detection) of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional liver CT | Active comparator | Radiation: Conventional CT (radiation), Drug: Conventional CT (contrast agent)Underwent conventional liver CT on HCC high-risk patient |
| Double low dose CT | Experimental | Radiation: Low radiation dose CT, Drug: Low contrast dose CT, Other: Deep-learning based contrast boosting algorithmsUnderwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Liver cirrhosis
- Tumor marker (aFP, PIVKA) elevation
- Nodular lesion on USG
- Received RFA for HCC
Key exclusion criteria (5 listed)
- hypersensitivity at iodine
- GFR under 30
- BMI over 30
- Nursing or pregnant women
- enrolled the other study
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 radiation dose CTUnderwent liver CT with 30% lower radiation dose | Radiation | Double low dose CT |
| Conventional CT (radiation)Underwent liver CT without change of radiation. | Radiation | Conventional liver CT |
| Low contrast dose CTAlso: Low contrast medium dosageUnderwent liver CT 20% lower dose contrast media. | Drug | Double low dose CT |
| Conventional CT (contrast agent)Also: Standard contrast medium dosageUnderwent liver CT without change of contrast media doses. | Drug | Conventional liver CT |
| Deep-learning based contrast boosting algorithmsApplied deep-learning based contrast boosting algorithms on acquired CT images | Other | Double low dose CT |
Primary outcome
Detection rate of solid focal lesion in liver
Time frame: 12 months after last patient's image work up
diagnostic performance
Quantitative image quality analysis
Time frame: Immediate after study enrollement
Contrast-to-Noise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- 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 radiation dose CT, Conventional CT (radiation) and Low contrast dose CT in people with Hepatocellular Carcinoma, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 14 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection rate of solid focal lesion in liver (time frame: 12 months after last patient's image work up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2022; AzTrials last refreshed its copy on 31 Oct 2026.