Hepatocellular Carcinoma (HCC)NCT02188901
Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study
A study testing Sonazoid-enhanced ultrasonography in people with Hepatocellular Carcinoma (HCC), run by Yonsei University at 1 site in South Korea.
Trial summary
B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast agent for ultrasonography, has reported to have superior sensitivity in detecting focal liver lesion since it has ability of Kupffer phase… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Sonazoid-enhanced ultrasonography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 523 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Oct 2014to 3 Aug 2016
- 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
- Patient 20 years old or older,
- Patient at high risk of HCC and is supposed to take ultrasonography,
- Patient who has no suspicious HCC on previous examinations or patient who undergoes the first surveillance,
- Patient who has liver cirrhosis proven by one of the following methods-liver biopsy (METAVIR score 4), identification of esophageal or gastric varix by endoscopically or radiologically, surface nodularity on ultrasonography, CT or MRI, platelet count less than 100,000/mm3, serum albumin less than 3.5 g/dl, or prothrombin time higher than 1.3 INR,
- Patient without contraindication for sonazoid,
- Patient willing to sign the informed consent
Who cannot join
- Patient on pregnancy or breast feeding,
- Patient with allergy to egg,
- Patient with left-to-right shunt, respiratory insufficiency, or severe pulmonary hypertension,
- Patient with history of HCC,
- Patient with history of malignancy other than HCC -
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University College of Medicine
Seoul, 120-752
About this study
B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast agent for ultrasonography, has reported to have superior sensitivity in detecting focal liver lesion since it has ability of Kupffer phase imaging as well as vascular phase imaging. So our aim is to compare the detection rate of early stage HCC and false referral rate of HCC between B-mode US and Sonazoid-enhanced ultrasonography (S-US) within the same prospective data group. Our hypothesis is that S-US has superior detection rate of early stage HCC (5%) than that of B-mode US (3%).
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Sonazoid-enhanced ultrasonography
- Keywords
- HCC, Sonazoid, Ultrasonography, Screening
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonazoid-enhanced ultrasonographyOther
Also called 0.015ml/kg of suspension containing 16μl of perflubutane microbubble and 2ml of diluent, IV (in the vein) on day 1
Sonazoid (perflubutane) [GE healthcare]
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | Not described Receives: Other: Sonazoid-enhanced ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of early stage HCC
Detection rate of early-stage HCC = (Number of confirmed early-stage HCC detected by a given modality) / (Total number of patients enrolled) x100
Measured: 30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US
False referral rate of HCC
False referral rate of HCC =
Measured: 30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study start15 Oct 2014
- Primary completion3 Aug 2016
- Study completion3 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188901
- Sponsor's protocol ID
- 4-2014-0337
- Status last verified
- Apr 2018
- First submitted
- 3 Jul 2014
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park JH, Park MS, Lee SJ, Jeong WK, Lee JY, Park MJ, Lee SS, Han K, Nam CM, Park SH, Lee KH. Contrast-enhanced US with Perfluorobutane for Hepatocellular Carcinoma Surveillance: A Multicenter Diagnostic Trial (SCAN). Radiology. 2019 Sep;292(3):638-646. doi: 10.1148/radiol.2019190183. Epub 2019 Jul 9.
PubMed 31287387Park JH, Park MS, Lee SJ, Jeong WK, Lee JY, Park MJ, Han K, Nam CM, Park SH, Lee KH. Contrast-enhanced US with Perfluorobutane(Sonazoid) used as a surveillance test for Hepatocellular Carcinoma (HCC) in Cirrhosis (SCAN): an exploratory cross-sectional study for a diagnostic trial. BMC Cancer. 2017 Apr 18;17(1):279. doi: 10.1186/s12885-017-3267-8.
PubMed 28420329
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study
- ClinicalTrials.gov ID
- NCT02188901
- Acronym / sponsor ID
- 4-2014-0337
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- HCC, Sonazoid, Ultrasonography, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 3 Aug 2016 (actual)
- Study completion
- 3 Aug 2016 (actual)
- First posted
- 14 Jul 2014 (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.
B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast agent for ultrasonography, has reported to have superior sensitivity in detecting focal liver lesion since it has ability of Kupffer phase imaging as well as vascular phase imaging. So our aim is to compare the detection rate of early stage HCC and false referral rate of HCC between B-mode US and Sonazoid-enhanced ultrasonography (S-US) within the same prospective data group. Our hypothesis is that S-US has superior detection rate of early stage HCC (5%) than that of B-mode US (3%).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Other: Sonazoid-enhanced ultrasonography |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient 20 years old or older,
- Patient at high risk of HCC and is supposed to take ultrasonography,
- Patient who has no suspicious HCC on previous examinations or patient who undergoes the first surveillance,
- Patient who has liver cirrhosis proven by one of the following methods-liver biopsy (METAVIR score 4), identification of esophageal or gastric varix by endoscopically or radiologically, surface nodularity on ultrasonography, CT or MRI, platelet count less than 100,000/mm3, serum albumin less than 3.5 g/dl, or prothrombin time higher than 1.3 INR,
- Patient without contraindication for sonazoid,
Key exclusion criteria (5 listed)
- Patient on pregnancy or breast feeding,
- Patient with allergy to egg,
- Patient with left-to-right shunt, respiratory insufficiency, or severe pulmonary hypertension,
- Patient with history of HCC,
- Patient with history of malignancy other than HCC -
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 |
|---|---|---|
| Sonazoid-enhanced ultrasonographyAlso: 0.015ml/kg of suspension containing 16μl of perflubutane microbubble and 2ml of diluent, IV (in the vein) on day 1Sonazoid (perflubutane) [GE healthcare] | Other | single arm |
Primary outcome
Detection rate of early stage HCC
Time frame: 30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US
Detection rate of early-stage HCC = (Number of confirmed early-stage HCC detected by a given modality) / (Total number of patients enrolled) x100
False referral rate of HCC
Time frame: 30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US
False referral rate of HCC =
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 26 Apr 2018.
- Derived from this study: PubMed 31287387Park JH, Park MS, Lee SJ, Jeong WK, Lee JY, Park MJ, Lee SS, Han K, Nam CM, Park SH, Lee KH. Contrast-enhanced US with Perfluorobutane for Hepatocellular Carcinoma Surveillance: A Multicenter Diagnostic Trial (SCAN). Radiology. 2019 Sep;292(3):638-646. doi: 10.1148/radiol.2019190183. Epub 2019 Jul 9.
- Derived from this study: PubMed 28420329Park JH, Park MS, Lee SJ, Jeong WK, Lee JY, Park MJ, Han K, Nam CM, Park SH, Lee KH. Contrast-enhanced US with Perfluorobutane(Sonazoid) used as a surveillance test for Hepatocellular Carcinoma (HCC) in Cirrhosis (SCAN): an exploratory cross-sectional study for a diagnostic trial. BMC Cancer. 2017 Apr 18;17(1):279. doi: 10.1186/s12885-017-3267-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonazoid-enhanced ultrasonography in people with Hepatocellular Carcinoma (HCC), run by Yonsei University 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 6 inclusion and 5 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 26 Apr 2018. 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?
Detection rate of early stage HCC (time frame: 30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US). The study lists 2 primary outcomes in all. 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 NCT02188901, which also lists 2 linked publications.
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 26 Apr 2018.