Liver MetastasesNCT05324046
Comparison Between LDCT With DL Recontruction and Standard Dose CT
An observational study of Liver Metastases, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
This prospective study aims to perform intra-individual comparison of the image quality between low dose liver CT with deep learning reconstruction and standard dose liver CT with iterative reconstruction in patients with liver metastasis. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Liver Metastases
- What is being tested?
- contrast-enhanced abdomen CT
- How many people
- 134 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 2 Jun 2022to 30 Jun 2024
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are referred to Radiology department for undergoing contrast-enhanced abdomen CT.
Who may be able to join
- patients with underlying malignancy and suspicion of liver metastasis
- patients with known liver metastasis and on follow-up
- AND scheduled for contrast enhanced abdomen CT
- signed informed consent
Who cannot join
- absolute or relative contra-indication for contrast-enhanced CT
- diffuse infiltrative liver lesion or multiple (> 10) metastases
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seoul
Ulsan University Hospital
Ulsan, 44033
About this study
Official title: Comparison of Low Dose Contrast Enhanced Abdominal CT With Deep Learning Reconstruction With Standard Dose CT With Iterative Reconstruction in Patients With Suspected Liver Metastases: A Prospective Multicenter Study
This prospective study aims to perform intra-individual comparison of the image quality between low dose liver CT with deep learning reconstruction and standard dose liver CT with iterative reconstruction in patients with liver metastasis.
- Conditions
- Liver Metastases
- Being tested
- contrast-enhanced abdomen CT
- Keywords
- CT, metastasis, liver
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast-enhanced abdomen CTDiagnostic test
contrast-enhanced abdomen CT using dual-source CT scanner using A-tube (67% radiation) and B-tube (33% radiation).
- full dose CT data (A +B tubes, 100%) are reconstructed with iterative reconstruction (conventional)
- low dose CT data (A-tube only, B-tube only) are reconstructed with deep learning commercially available software.
- images are reconstructed using full dose (A- \& B- tubes) and smaller dose (A-tube only, B-tube only)
| Study group | Role | What they receive |
|---|---|---|
| Liver metastasis | Patients with suspicion of liver metastasis and scheduled for CT Receives: Diagnostic Test: contrast-enhanced abdomen CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver lesion conspicuity
graded on a five-point scale (1-5) with higher score indicates a better conscpicuity.
Measured: 6 months after the CT scan
Secondary outcomes (1)
liver lesion detectability
liver lesion detection rate on standard dose CT and low dose CT by blinded reviewers
Measured: 6 months after the CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start2 Jun 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (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 Liver MetastasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 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
- NCT05324046
- Sponsor's protocol ID
- 2022-0410
- Status last verified
- Aug 2023
- First submitted
- 4 Apr 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee TY, Yoon JH, Park JY, Park SH, Kim H, Lee CM, Choi Y, Lee JM. Intraindividual Comparison of Image Quality Between Low-Dose and Ultra-Low-Dose Abdominal CT With Deep Learning Reconstruction and Standard-Dose Abdominal CT Using Dual-Split Scan. Invest Radiol. 2025 Jul 1;60(7):454-462. doi: 10.1097/RLI.0000000000001151. Epub 2025 Jan 28.
PubMed 39874436
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low Dose Contrast Enhanced Abdominal CT With Deep Learning Reconstruction With Standard Dose CT With Iterative Reconstruction in Patients With Suspected Liver Metastases: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05324046
- Acronym / sponsor ID
- 2022-0410
- Conditions
- Liver Metastases
- Keywords
- CT, metastasis, liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Apr 2022 (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 prospective study aims to perform intra-individual comparison of the image quality between low dose liver CT with deep learning reconstruction and standard dose liver CT with iterative reconstruction in patients with liver metastasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver metastasis | – | Diagnostic Test: contrast-enhanced abdomen CTPatients with suspicion of liver metastasis and scheduled for CT |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are referred to Radiology department for undergoing contrast-enhanced abdomen CT.
Key inclusion criteria (4 listed)
- patients with underlying malignancy and suspicion of liver metastasis
- patients with known liver metastasis and on follow-up
- AND scheduled for contrast enhanced abdomen CT
- signed informed consent
Key exclusion criteria (2 listed)
- absolute or relative contra-indication for contrast-enhanced CT
- diffuse infiltrative liver lesion or multiple (> 10) metastases
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 |
|---|---|---|
| contrast-enhanced abdomen CTcontrast-enhanced abdomen CT using dual-source CT scanner using A-tube (67% radiation) and B-tube (33% radiation). * full dose CT data (A +B tubes, 100%) are reconstructed with iterative reconstruction (conventional) * low dose CT data (A-tube only, B-tube only) are reconstructed with deep learning commercially available software. * images are reconstructed using full dose (A- \& B- tubes) and smaller dose (A-tube only, B-tube only) | Diagnostic test | Liver metastasis |
Primary outcome
liver lesion conspicuity
Time frame: 6 months after the CT scan
graded on a five-point scale (1-5) with higher score indicates a better conscpicuity.
1 secondary outcome
liver lesion detectability
Time frame: 6 months after the CT scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Derived from this study: PubMed 39874436Lee TY, Yoon JH, Park JY, Park SH, Kim H, Lee CM, Choi Y, Lee JM. Intraindividual Comparison of Image Quality Between Low-Dose and Ultra-Low-Dose Abdominal CT With Deep Learning Reconstruction and Standard-Dose Abdominal CT Using Dual-Split Scan. Invest Radiol. 2025 Jul 1;60(7):454-462. doi: 10.1097/RLI.0000000000001151. Epub 2025 Jan 28.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Metastases, run by Seoul National University Hospital at 2 sites 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 2 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
liver lesion conspicuity (time frame: 6 months after the CT scan). 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 NCT05324046, 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 18 Aug 2023.