HCCNCT03045445
"Double Low-Dose" DECT for HCC Imaging
A study testing Double Low-Dose protocol CT and Standard protocol CT in people with HCC, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Hypothesis: double low-dose protocol provide better lesion conspicuity than standard protocol CT in patients at high-risk of HCC. patients who are scheduled for CECT for HCC diagnosis or surveillance are eligible for this study and allocated to either standard protocol or double-low dose protocol using spectral CT… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HCC
- What is being tested?
- Double Low-Dose protocol CT and Standard protocol CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2017to 25 Sep 2019
- 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 of HCC (chronic hepatitis B or C, or LC of any cause)
- signed informed consent
- scheduled for contrast enhanced liver CT for HCC surveillance or diagnosis
Who cannot join
- no risk factor for HCC
- history of iodine hypersensitivity
- renal dysfunction (Estimated GFR < 30mL/min/1.73m2) or on dialysis
- metformin medication within 48 hours
- any other contraindication of CE-CT
- BMI > or = 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Image Quality Between "Double Low-Dose" Dual Energy Liver CT and Standard Contrast Enhanced Liver CT in Patients at High-risk of HCC: Prospective, Randomized Single Center Study
Hypothesis: double low-dose protocol provide better lesion conspicuity than standard protocol CT in patients at high-risk of HCC.
patients who are scheduled for CECT for HCC diagnosis or surveillance are eligible for this study and allocated to either standard protocol or double-low dose protocol using spectral CT with low radiation dose and low dose of contrast media, within clinically accpetable range.
- Conditions
- HCC
- Being tested
- Double Low-Dose protocol CT, Standard protocol CT
- Keywords
- CT, dual energy, low dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Low-Dose protocol CTDiagnostic test
Double low-dose protocol CT (Low radiation dose quadriphasic liver CT and low dose of iodine contrast media) at spectral dual energy CT scanner
Standard protocol CTDiagnostic test
standard protocol CT (standard dose quadriphasic liver CT and standard dose of iodine contrast media) at spectral dual energy CT scanner
| Study group | Role | What they receive |
|---|---|---|
| Double Low-Dose protocol CT | Experimental | Low radiation dose + low amount of iodine contrast media at spectral CT (Philips Healthcare) Receives: Diagnostic Test: Double Low-Dose protocol CT |
| Standard protocol CT | Active comparator | Standard protocol quadriphasic liver CT according to current liver CT protocol in our institution, at spectral CT (Philips Healthcare) Receives: Diagnostic Test: Standard protocol CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion conspicuity
qualitative conspicuity assessment of focal liver lesion
Measured: 12 months after CT
Secondary outcomes (9)
image noise
qualitative analysis
Measured: 12 months after CT
beam hardening artifact
qualitative analysis
Measured: 12 months after CT
hepatic artery conspicuity
qualitative analysis
Measured: 12 months after CT
portal vein conspicuity
qualitative analysis
Measured: 12 months after CT
image texture (plasticity)
qualitative analysis
Measured: 12 months after CT
overall image quality
qualitative analysis
Measured: 12 months after CT
presence of hepatic artery anatomic variation
yes, no, indeterminate and if yes) describe the variation
Measured: 12 months after CT
sensitivity to detect HCC
according to LI-RADS
Measured: 18 months after CT
radiation dose
CTDIvol, DLP, and effective dose
Measured: 1 month after CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start30 May 2017
- Primary completion21 Mar 2018
- Study completion25 Sep 2019
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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- 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
- NCT03045445
- Sponsor's protocol ID
- SNUH-2016-2830
- Status last verified
- Mar 2021
- First submitted
- 4 Feb 2017
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoon JH, Chang W, Lee ES, Lee SM, Lee JM. Double Low-Dose Dual-Energy Liver CT in Patients at High-Risk of HCC: A Prospective, Randomized, Single-Center Study. Invest Radiol. 2020 Jun;55(6):340-348. doi: 10.1097/RLI.0000000000000643.
PubMed 31917765
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Image Quality Between "Double Low-Dose" Dual Energy Liver CT and Standard Contrast Enhanced Liver CT in Patients at High-risk of HCC: Prospective, Randomized Single Center Study
- ClinicalTrials.gov ID
- NCT03045445
- Acronym / sponsor ID
- SNUH-2016-2830
- Conditions
- HCC
- Keywords
- CT, dual energy, low dose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 30 May 2017 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 7 Feb 2017 (estimated)
- 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.
Hypothesis: double low-dose protocol provide better lesion conspicuity than standard protocol CT in patients at high-risk of HCC.
patients who are scheduled for CECT for HCC diagnosis or surveillance are eligible for this study and allocated to either standard protocol or double-low dose protocol using spectral CT with low radiation dose and low dose of contrast media, within clinically accpetable range.
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 |
|---|---|---|
| Double Low-Dose protocol CT | Experimental | Diagnostic Test: Double Low-Dose protocol CTLow radiation dose + low amount of iodine contrast media at spectral CT (Philips Healthcare) |
| Standard protocol CT | Active comparator | Diagnostic Test: Standard protocol CTStandard protocol quadriphasic liver CT according to current liver CT protocol in our institution, at spectral CT (Philips Healthcare) |
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 of HCC (chronic hepatitis B or C, or LC of any cause)
- signed informed consent
- scheduled for contrast enhanced liver CT for HCC surveillance or diagnosis
Key exclusion criteria (6 listed)
- no risk factor for HCC
- history of iodine hypersensitivity
- renal dysfunction (Estimated GFR < 30mL/min/1.73m2) or on dialysis
- metformin medication within 48 hours
- any other contraindication of CE-CT
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 protocol CTDouble low-dose protocol CT (Low radiation dose quadriphasic liver CT and low dose of iodine contrast media) at spectral dual energy CT scanner | Diagnostic test | Double Low-Dose protocol CT |
| Standard protocol CTstandard protocol CT (standard dose quadriphasic liver CT and standard dose of iodine contrast media) at spectral dual energy CT scanner | Diagnostic test | Standard protocol CT |
Primary outcome
Lesion conspicuity
Time frame: 12 months after CT
qualitative conspicuity assessment of focal liver lesion
9 secondary outcomes
image noise
Time frame: 12 months after CT
beam hardening artifact
Time frame: 12 months after CT
hepatic artery conspicuity
Time frame: 12 months after CT
portal vein conspicuity
Time frame: 12 months after CT
image texture (plasticity)
Time frame: 12 months after CT
overall image quality
Time frame: 12 months after CT
presence of hepatic artery anatomic variation
Time frame: 12 months after CT
sensitivity to detect HCC
Time frame: 18 months after CT
radiation dose
Time frame: 1 month after CT
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 19 Mar 2021.
- Derived from this study: PubMed 31917765Yoon JH, Chang W, Lee ES, Lee SM, Lee JM. Double Low-Dose Dual-Energy Liver CT in Patients at High-Risk of HCC: A Prospective, Randomized, Single-Center Study. Invest Radiol. 2020 Jun;55(6):340-348. doi: 10.1097/RLI.0000000000000643.
- 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 protocol CT and Standard protocol CT in people with HCC, 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: finished, as of the sponsor's last update on 19 Mar 2021. 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?
Lesion conspicuity (time frame: 12 months after CT). 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 NCT03045445, 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 19 Mar 2021.