Carcinoma, HepatocellularNCT04027556
Low-contrast Dose Liver CT Using Lean Body Weight Low Monoenergetic Images and Deep Learning-based Reconstruction
A study testing low dose CT contrast media - lean body weight and Standard dose CT contrast media in people with Carcinoma, Hepatocellular and Body Weight, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to assess whether the acceptable image quality is achievable using low monoenergetic imaging of dual-energy CT with deep learning-based denoising, and low contrast media dose calculated based on lean body weight for the detection of hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Body Weight
- What is being tested?
- low dose CT contrast media - lean body weight and Standard dose CT contrast media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jun 2019to 10 Feb 2022
- 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
Who cannot join
- not a high risk group for developing HCC
- body mass index is equal to or larger than 30 kg/m^2
- suspected HCC > 5cm in diameter
- received locoregional treatment or surgery for HCC within 3 months
- congestive hepatopathy
- no venous access on forearm
- anticipated beam hardening artifact due to prosthesis
- relative/absolute contraindication of contrast-enhanced CT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-contrast Dose Liver CT Using Lean Body Weight, Low Monoenergetic Images and Deep Learning-based Reconstruction for Hepatocellular Carcinoma
This study aims to assess whether the acceptable image quality is achievable using low monoenergetic imaging of dual-energy CT with deep learning-based denoising, and low contrast media dose calculated based on lean body weight for the detection of hepatocellular carcinoma.
Read the detailed description
The use of iodinated contrast media in CT is associated with an immediate hypersensitivity reaction in a dose-dependent manner. Therefore, it is important to reduce the contrast dose for CT exams in patients who are required repeated CT examinations, including patients with hepatocellular carcinoma (HCC). Low monoenergetic images of dual-energy CT can provide higher iodine contrast than conventional images, thus enabling reduction of contrast media. The high image noise in low monoenergetic images may be improved by using model-based IR techniques and deep learning-based denoising (DLD) algorithms. Besides, lean body weight (LBW)-based contrast dose determination can be another option to reduce contrast media dose compared with total body weight-based dose determination since the volumes of blood and liver are not strictly proportional to total body weight. Therefore, we surmised that 50 keV images reconstructed with DLD algorithms with reducing iodine load by 30% based on LBW could produce the comparable image quality and lesion conspicuity compared with standard iodine-dose 120kVp images.
In this single-center prospective, randomized clinical trial, we aimed to investigate the effectiveness of low-contrast dose CT using 50 keV and DLD technique compared with the standard contrast-dose protocol using model-based IR in patients at high risk of HCC.
- Conditions
- Carcinoma, Hepatocellular, Body Weight
- Being tested
- low dose CT contrast media - lean body weight, Standard dose CT contrast media
- Medical subject headings
- Carcinoma, Hepatocellular, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose CT contrast media - lean body weightOther
CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 450mgI/kg based on lean body weight.
Standard dose CT contrast mediaOther
CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 560mgI/kg based on total body weight.
| Study group | Role | What they receive |
|---|---|---|
| 50 keV DLD images of the LBW-based low-dose group | Experimental | Low CT contrast media dose calculated based on lean body weight and low monoenergetic images of dual-energy CT with deep learning-based denoising Receives: Other: low dose CT contrast media - lean body weight |
| ADMIRE images of the standard-contrast dose group | Active comparator | Standard CT contrast media dose calculated based on total body weight and conventional images with full model-based iterative reconstruction Receives: Other: Standard dose CT contrast media |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCC conspicuity
qualitative scoring for focal lesion depiction on four-point scale (1: worst, 4: excellent, representative value is average score)
Measured: 6 months after complete enrollment
Secondary outcomes (7)
Image noise
qualitative scoring for image noise on four-point scale (1: worst, 4: excellent, representative value is average score)
Measured: 12 months after complete enrollment
Image contrast
qualitative scoring for image contrast on four-point scale (1: worst, 4: excellent, representative value is average score)
Measured: 12 months after complete enrollment
Overall image quality
qualitative scoring for image quality on four-point scale (1: worst, 4: excellent, representative value is average score)
Measured: 6 months after complete enrollment
Lesion detection
assessment of focal liver lesion (HCC) on CT according to Liver Imaging Reporting and Data System (LI-RADS)
Measured: 12 months after complete enrollment
Hounsfield unit
measurement of hounsfield unit in aorta, portal vein, liver parenchyma, and paraspinal muscles
Measured: 3 months after complete enrollment
Contrast media dose
administered contrast media dose in each group
Measured: 3 months after complete enrollment
Radiation dose
measured radiation dose in each group
Measured: 3 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 posted22 Jul 2019
- Study start27 Jun 2019
- Primary completion26 Aug 2020
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- 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
- NCT04027556
- Sponsor's protocol ID
- SNUH-2019-0344
- Status last verified
- Apr 2022
- First submitted
- 18 Jul 2019
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-contrast Dose Liver CT Using Lean Body Weight, Low Monoenergetic Images and Deep Learning-based Reconstruction for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04027556
- Acronym / sponsor ID
- SNUH-2019-0344
- Conditions
- Carcinoma, Hepatocellular, Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 22 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 assess whether the acceptable image quality is achievable using low monoenergetic imaging of dual-energy CT with deep learning-based denoising, and low contrast media dose calculated based on lean body weight for the detection of hepatocellular carcinoma.
Detailed description
The use of iodinated contrast media in CT is associated with an immediate hypersensitivity reaction in a dose-dependent manner. Therefore, it is important to reduce the contrast dose for CT exams in patients who are required repeated CT examinations, including patients with hepatocellular carcinoma (HCC). Low monoenergetic images of dual-energy CT can provide higher iodine contrast than conventional images, thus enabling reduction of contrast media. The high image noise in low monoenergetic images may be improved by using model-based IR techniques and deep learning-based denoising (DLD) algorithms. Besides, lean body weight (LBW)-based contrast dose determination can be another option to reduce contrast media dose compared with total body weight-based dose determination since the volumes of blood and liver are not strictly proportional to total body weight. Therefore, we surmised that 50 keV images reconstructed with DLD algorithms with reducing iodine load by 30% based on LBW could produce the comparable image quality and lesion conspicuity compared with standard iodine-dose 120kVp images.
In this single-center prospective, randomized clinical trial, we aimed to investigate the effectiveness of low-contrast dose CT using 50 keV and DLD technique compared with the standard contrast-dose protocol using model-based IR in patients at high risk of HCC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 keV DLD images of the LBW-based low-dose group | Experimental | Other: low dose CT contrast media - lean body weightLow CT contrast media dose calculated based on lean body weight and low monoenergetic images of dual-energy CT with deep learning-based denoising |
| ADMIRE images of the standard-contrast dose group | Active comparator | Other: Standard dose CT contrast mediaStandard CT contrast media dose calculated based on total body weight and conventional images with full model-based iterative reconstruction |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- High risk group for developing HCC
- Scheduled contrast-enhanced CT for HCC diagnosis or surveillance
Key exclusion criteria (8 listed)
- not a high risk group for developing HCC
- body mass index is equal to or larger than 30 kg/m^2
- suspected HCC > 5cm in diameter
- received locoregional treatment or surgery for HCC within 3 months
- congestive hepatopathy
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 media - lean body weightCT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 450mgI/kg based on lean body weight. | Other | 50 keV DLD images of the LBW-based low-dose group |
| Standard dose CT contrast mediaCT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 560mgI/kg based on total body weight. | Other | ADMIRE images of the standard-contrast dose group |
Primary outcome
HCC conspicuity
Time frame: 6 months after complete enrollment
qualitative scoring for focal lesion depiction on four-point scale (1: worst, 4: excellent, representative value is average score)
7 secondary outcomes
Image noise
Time frame: 12 months after complete enrollment
Image contrast
Time frame: 12 months after complete enrollment
Overall image quality
Time frame: 6 months after complete enrollment
Lesion detection
Time frame: 12 months after complete enrollment
Hounsfield unit
Time frame: 3 months after complete enrollment
Contrast media dose
Time frame: 3 months after complete enrollment
Radiation dose
Time frame: 3 months after complete enrollment
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 4 May 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 dose CT contrast media - lean body weight and Standard dose CT contrast media in people with Carcinoma, Hepatocellular and Body Weight, 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 2 inclusion and 8 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 4 May 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?
HCC conspicuity (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?
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 4 May 2022; AzTrials last refreshed its copy on 30 Oct 2026.