HCCNCT04195971
Dual Arterial Phase Liver CT in Patients With Suspected Portal Hypertension
A study testing Liver CT in people with HCC and Cirrhosis, Liver, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Patients with liver cirrhosis is at risk of developing HCC. To diagnose or detect HCC at CT/MRI, optimal late arterial phase (LAP) acquisition is critical to capture the tumor. For LAP acquisition, bolus-tracking is often used at CT. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HCC, Cirrhosis, Liver
- What is being tested?
- Liver CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Dec 2019to Jun 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
- Older than 20 years
- Liver cirrhosis diagnosed with characteristic imaging feature or histology
- Presence of portal hypertension sign (splenomegaly and varices)
- Scheduled for liver CT
- And signed informed consent
Who cannot join
- Relative or absolute contra-indication of contrast-enhanced CT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiphasic Liver CT Scan Including Dual Arterial Phase Imaging in Patients With Liver Cirrhosis and Suspected Portal Hypertension: Evaluation of Acquisition of Appropriate Late Arterial Phase Imaging
Patients with liver cirrhosis is at risk of developing HCC. To diagnose or detect HCC at CT/MRI, optimal late arterial phase (LAP) acquisition is critical to capture the tumor. For LAP acquisition, bolus-tracking is often used at CT. In patients with portal hypertension, however, bolus-tracking occasionally capture early arterial phase which may be related with slow portomesenteric flow. In this study, we obtain dual arterial phase in patients with suspected portal hypertension and determine whether this protocol (dual arterial phase) would provide higher incidence of LAP acquisition than single arterial phase acquisition.
- Conditions
- HCC, Cirrhosis, Liver
- Being tested
- Liver CT
- Keywords
- CT
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver CTDiagnostic test
Liver CT with precontrast, dual arterial phase, portal venous phase, and delayed phase.
| Study group | Role | What they receive |
|---|---|---|
| Liver CT with dual arterial phase | Experimental | Not described Receives: Diagnostic Test: Liver CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of optimal late arterial phase acquisition
incidences of optimal late arterial phase acquisition in 1st and 2nd acquisition of arterial phase in this protocol (dual arterial phase) CT.
Measured: 1 months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start26 Dec 2019
- Primary completion21 Sep 2020
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 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
- NCT04195971
- Sponsor's protocol ID
- SNUH-2019-2587
- Status last verified
- Mar 2021
- First submitted
- 10 Dec 2019
- Last updated
- 17 Mar 2021
- 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 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiphasic Liver CT Scan Including Dual Arterial Phase Imaging in Patients With Liver Cirrhosis and Suspected Portal Hypertension: Evaluation of Acquisition of Appropriate Late Arterial Phase Imaging
- ClinicalTrials.gov ID
- NCT04195971
- Acronym / sponsor ID
- SNUH-2019-2587
- Conditions
- HCC, Cirrhosis, Liver
- Keywords
- CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 12 Dec 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.
Patients with liver cirrhosis is at risk of developing HCC. To diagnose or detect HCC at CT/MRI, optimal late arterial phase (LAP) acquisition is critical to capture the tumor. For LAP acquisition, bolus-tracking is often used at CT. In patients with portal hypertension, however, bolus-tracking occasionally capture early arterial phase which may be related with slow portomesenteric flow. In this study, we obtain dual arterial phase in patients with suspected portal hypertension and determine whether this protocol (dual arterial phase) would provide higher incidence of LAP acquisition than single arterial phase acquisition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver CT with dual arterial phase | Experimental | Diagnostic Test: Liver CT |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older than 20 years
- Liver cirrhosis diagnosed with characteristic imaging feature or histology
- Presence of portal hypertension sign (splenomegaly and varices)
- Scheduled for liver CT
- And signed informed consent
Key exclusion criteria (1 listed)
- Relative or absolute contra-indication of contrast-enhanced 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 |
|---|---|---|
| Liver CTLiver CT with precontrast, dual arterial phase, portal venous phase, and delayed phase. | Diagnostic test | Liver CT with dual arterial phase |
Primary outcome
Incidence of optimal late arterial phase acquisition
Time frame: 1 months after study completion
incidences of optimal late arterial phase acquisition in 1st and 2nd acquisition of arterial phase in this protocol (dual arterial phase) CT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- 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 Liver CT in people with HCC and Cirrhosis, Liver, 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 5 inclusion and 1 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 17 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?
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?
Incidence of optimal late arterial phase acquisition (time frame: 1 months after 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 17 Mar 2021.