Hepatocellular CarcinomaNCT04847726
Contrast-enhanced Ultrasound With Perfluorobutane and Sulfur Hexafluoride for Hepatocellular Carcinoma
A study testing contrast enhanced ultrasound, Dynamic CT and Liver MRI in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Intra-individual comparison of diagnostic performance of CEUS With perfluorobutane and sulfur hexafluoride for HCC in high-risk Individuals, and their role in the diagnostic algorithm of HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- contrast enhanced ultrasound, Dynamic CT and Liver MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jun 2020to 30 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high-risk for HCC (liver cirrhosis, chronic hepatitis B)
- treatment-naive hepatic nodule (>= 1cm) on preceding CT, MR or ultrasound
Who cannot join
- severe cardiopulmonary dysfunction
- pregnancy
- refusal to enroll study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03038
About this study
Official title: Perfluorobutane-enhanced Ultrasound as a Diagnostic Tool for Hepatocellular Carcinoma in Individuals With High Risk: Intraindividual Comparison With Sulfur Hexafluoride-enhanced Ultrasound
Intra-individual comparison of diagnostic performance of CEUS With perfluorobutane and sulfur hexafluoride for HCC in high-risk Individuals, and their role in the diagnostic algorithm of HCC.
Read the detailed description
The investigators would compare the diagnostic performance for HCC at high-risk individuals between both USG contrast agents.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- contrast enhanced ultrasound, Dynamic CT, Liver MRI
- Keywords
- HCC, Contrast-enhanced ultrasound, Perfluorobutane, Sulfur hexafluoride
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast enhanced ultrasoundDiagnostic test
contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride
Dynamic CTDiagnostic test
Participants underwent dynamic CT for hepatic lesion
Liver MRIDiagnostic test
Participants underwent liver MRI for hepatic lesion
| Study group | Role | What they receive |
|---|---|---|
| CEUS with perfluorobutane and sulfur hexafluoride | Experimental | Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion. Receives: Diagnostic Test: contrast enhanced ultrasound; Diagnostic Test: Dynamic CT; Diagnostic Test: Liver MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy for HCC: non-inferiority test
The per-lesion diagnostic accuracy for HCC of CEUS with perfluorobutane and sulfur hexafluoride using the same diagnostic criteria (arterial phase hyperenehancement with mild and late (≥ 60 sec) washout).
Measured: up to 3 months
Secondary outcomes (1)
Diagnostic performance of perfulorobutane enhanced USG using different definition of washout
Per-lesion sensitivity and specificity for diagnosing HCC using different time windows for assessing washout in PFB-US
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start9 Jun 2020
- Primary completion30 Jul 2021
- Study completion30 Oct 2021
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 Hepatocellular CarcinomaStudies 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
- Model description
- Study participants underwent contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride. The diagnostic performance will be compared intra-individually.
- Masking
- None (open label)
- Enrolment
- 110 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, Dr., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847726
- Sponsor's protocol ID
- SNUH-1807-166
- Status last verified
- Dec 2021
- First submitted
- 9 Apr 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kang HJ, Lee JM, Yoon JH, Yoo J, Choi Y, Joo I, Han JK. Sonazoid versus SonoVue(R) for Diagnosing Hepatocellular Carcinoma Using Contrast-Enhanced Ultrasound in At-Risk Individuals: A Prospective, Single-Center, Intraindividual, Noninferiority Study. Korean J Radiol. 2022 Nov;23(11):1067-1077. doi: 10.3348/kjr.2022.0388. Epub 2022 Sep 30.
PubMed 36196767
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfluorobutane-enhanced Ultrasound as a Diagnostic Tool for Hepatocellular Carcinoma in Individuals With High Risk: Intraindividual Comparison With Sulfur Hexafluoride-enhanced Ultrasound
- ClinicalTrials.gov ID
- NCT04847726
- Acronym / sponsor ID
- SNUH-1807-166
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, Contrast-enhanced ultrasound, Perfluorobutane, Sulfur hexafluoride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 19 Apr 2021 (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.
Intra-individual comparison of diagnostic performance of CEUS With perfluorobutane and sulfur hexafluoride for HCC in high-risk Individuals, and their role in the diagnostic algorithm of HCC.
Detailed description
The investigators would compare the diagnostic performance for HCC at high-risk individuals between both USG contrast agents.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study participants underwent contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride. The diagnostic performance will be compared intra-individually.
| Arm | Type | Receives |
|---|---|---|
| CEUS with perfluorobutane and sulfur hexafluoride | Experimental | Diagnostic Test: contrast enhanced ultrasound, Diagnostic Test: Dynamic CT, Diagnostic Test: Liver MRIContrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- high-risk for HCC (liver cirrhosis, chronic hepatitis B)
- treatment-naive hepatic nodule (>= 1cm) on preceding CT, MR or ultrasound
Key exclusion criteria (3 listed)
- severe cardiopulmonary dysfunction
- pregnancy
- refusal to enroll study
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 ultrasoundcontrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride | Diagnostic test | CEUS with perfluorobutane and sulfur hexafluoride |
| Dynamic CTParticipants underwent dynamic CT for hepatic lesion | Diagnostic test | CEUS with perfluorobutane and sulfur hexafluoride |
| Liver MRIParticipants underwent liver MRI for hepatic lesion | Diagnostic test | CEUS with perfluorobutane and sulfur hexafluoride |
Primary outcome
Diagnostic accuracy for HCC: non-inferiority test
Time frame: up to 3 months
The per-lesion diagnostic accuracy for HCC of CEUS with perfluorobutane and sulfur hexafluoride using the same diagnostic criteria (arterial phase hyperenehancement with mild and late (≥ 60 sec) washout).
1 secondary outcome
Diagnostic performance of perfulorobutane enhanced USG using different definition of washout
Time frame: up to 3 months
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 7 Dec 2021.
- Derived from this study: PubMed 36196767Kang HJ, Lee JM, Yoon JH, Yoo J, Choi Y, Joo I, Han JK. Sonazoid versus SonoVue(R) for Diagnosing Hepatocellular Carcinoma Using Contrast-Enhanced Ultrasound in At-Risk Individuals: A Prospective, Single-Center, Intraindividual, Noninferiority Study. Korean J Radiol. 2022 Nov;23(11):1067-1077. doi: 10.3348/kjr.2022.0388. Epub 2022 Sep 30.
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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, Dr. 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 contrast enhanced ultrasound, Dynamic CT and Liver MRI in people with Hepatocellular Carcinoma, 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 3 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 7 Dec 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?
Diagnostic accuracy for HCC: non-inferiority test (time frame: up to 3 months). 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 NCT04847726, 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 7 Dec 2021.