Metastasis to LiverNCT05790590
Comparison of Image Quality Between "Double Low Dose" Liver CT and Standard Liver CT
A study testing Double low dose CT and Standard dose CT in people with Metastasis to Liver and Colorectal Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In patients with malignancies, contrast-enhanced abdominal CT (hereafter abdominal CT) plays an important role in detecting carcinoma recurrence and assessing treatment response. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastasis to Liver, Colorectal Cancer
- What is being tested?
- Double low dose CT and Standard dose CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2023to 30 Jun 2025
- 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
- colorectal cancer (CRC) patients
- on surveillance or monitoring for liver metastasis (of CRC)
Who cannot join
- any relative or absolute contra-indication of CECT
- diffuse infiltrative type of liver metastasis or on monitoring for too many liver lesions
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Hyuna Jung, RN, 82-2-2072-4177, jha5375@snu.ac.kr
Jeong Min Lee, MD
About this study
Official title: Comparison of Image Quality Between "Double Low Dose" Liver CT Using AI-based Iodine Boosting Reconstruction and Standard Contrast-enhanced Liver CT in Patients With Colorectal Cancer: Prospective, Randomized, Non-inferiority Trial
In patients with malignancies, contrast-enhanced abdominal CT (hereafter abdominal CT) plays an important role in detecting carcinoma recurrence and assessing treatment response. In this study, we aim to investigate whether such a "double low" dose CT is feasible in patients with liver metastases of colorectal cancer using a vendor-agnostic artificial intelligence-based noise reduction and contrast enhancement software.
- Conditions
- Metastasis to Liver, Colorectal Cancer
- Being tested
- Double low dose CT, Standard dose CT
- Keywords
- CT
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double low dose CTDiagnostic test
Simultaneous reduction of both radiation dose and contrast media dose
Standard dose CTDiagnostic test
CT with standard radiation dose and contrast media dose
| Study group | Role | What they receive |
|---|---|---|
| Standard dose CT | Active comparator | Standard dose protocol CT using standard radiation dose (120 kVp) and standard dose of contrast media, and reconstructed with commercially available reconstruction algorithm of the CT scanner. Receives: Diagnostic Test: Standard dose CT |
| Double low dose CT | Experimental | Double low dose protocol CT using low radiation dose (120 kVp \& 70% of reference mAs of standard dose CT) and low dose of contrast media, and reconstructed with commercially available vendor-agonistic AI-based software. Receives: Diagnostic Test: Double low dose CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
lesion conspicuity on portal venous phase
qualitative analysis of lesion conspicuity on portal venous phase on five-point scale (higher score indicates better conspicuity).
Lesion conspicuity is compared between the two arms.
Measured: 6 months after primary study completion.
Secondary outcomes (4)
lesion conspicuity on arterial phase
qualitative analysis of lesion conspicuity on arterial phase on five-point scale (higher score indicates better conspicuity) Lesion conspicuity is compared between the two arms.
Measured: 6 months after primary study completion.
lesion detectability
lesion detectability is compared between the two arms, compared with reference standard. Figure-of-merit was obtained.
Measured: 12 months after primary study completion.
Radiation dose
Dose-length product (mGy*cm) is compared between the two arms.
Measured: 1 month after primary study completion
Contrast media (CM) dose
The amount of CM dose is compared between the two arms.
Measured: 1 month after primary study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start30 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastasis to LiverStudies 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
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- 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
- NCT05790590
- Sponsor's protocol ID
- SNUH-2022-3274
- Status last verified
- Jun 2023
- First submitted
- 17 Mar 2023
- Last updated
- 5 Jun 2023
- 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 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Image Quality Between "Double Low Dose" Liver CT Using AI-based Iodine Boosting Reconstruction and Standard Contrast-enhanced Liver CT in Patients With Colorectal Cancer: Prospective, Randomized, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05790590
- Acronym / sponsor ID
- SNUH-2022-3274
- Conditions
- Metastasis to Liver, Colorectal Cancer
- Keywords
- CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 30 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Mar 2023 (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.
In patients with malignancies, contrast-enhanced abdominal CT (hereafter abdominal CT) plays an important role in detecting carcinoma recurrence and assessing treatment response. In this study, we aim to investigate whether such a "double low" dose CT is feasible in patients with liver metastases of colorectal cancer using a vendor-agnostic artificial intelligence-based noise reduction and contrast enhancement software.
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 |
|---|---|---|
| Standard dose CT | Active comparator | Diagnostic Test: Standard dose CTStandard dose protocol CT using standard radiation dose (120 kVp) and standard dose of contrast media, and reconstructed with commercially available reconstruction algorithm of the CT scanner. |
| Double low dose CT | Experimental | Diagnostic Test: Double low dose CTDouble low dose protocol CT using low radiation dose (120 kVp \& 70% of reference mAs of standard dose CT) and low dose of contrast media, and reconstructed with commercially available vendor-agonistic AI-based software. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- colorectal cancer (CRC) patients
- on surveillance or monitoring for liver metastasis (of CRC)
Key exclusion criteria (2 listed)
- any relative or absolute contra-indication of CECT
- diffuse infiltrative type of liver metastasis or on monitoring for too many liver lesions
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 |
|---|---|---|
| Double low dose CTSimultaneous reduction of both radiation dose and contrast media dose | Diagnostic test | Double low dose CT |
| Standard dose CTCT with standard radiation dose and contrast media dose | Diagnostic test | Standard dose CT |
Primary outcome
lesion conspicuity on portal venous phase
Time frame: 6 months after primary study completion.
qualitative analysis of lesion conspicuity on portal venous phase on five-point scale (higher score indicates better conspicuity). Lesion conspicuity is compared between the two arms.
4 secondary outcomes
lesion conspicuity on arterial phase
Time frame: 6 months after primary study completion.
lesion detectability
Time frame: 12 months after primary study completion.
Radiation dose
Time frame: 1 month after primary study completion
Contrast media (CM) dose
Time frame: 1 month after primary study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- 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 Double low dose CT and Standard dose CT in people with Metastasis to Liver and Colorectal Cancer, 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 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 5 Jun 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?
Contact Hyuna Jung (82-2-2072-4177, jha5375@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lesion conspicuity on portal venous phase (time frame: 6 months after primary study completion.). 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 5 Jun 2023.