Hepatocellular CarcinomaNCT00822991
Sonazoid Enhanced Liver Cancer Trial for Early Detection
A study testing CE-US (Sonazoid™) and B-mode US in people with Hepatocellular Carcinoma and Liver Cirrhosis, run by Kindai University at 1 site in Japan.
Trial summary
The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk patients for hepatocarcinogenesis,Furthermore, to… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis, Hepatitis B
- What is being tested?
- CE-US (Sonazoid™) and B-mode US
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2009to Dec 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
- Age over 20
- HBV or HCV related liver cirrhosis
- No history of HCC
- Diagnosed as liver cirrhosis histologically or clinically Histologically confirmed by liver biopsy Confirmed by formula of diagnosing cirrhosis Radiological finding Finding of portal hypertension Platelet<130,000
- Inpatient or outpatient
- Patients who signed a written informed consent form
Who cannot join
- History of hypersensitivity to egg yolk
- Pregnant or lactating women and women who may be pregnant
- Severe liver dysfunction(AST, ALT,or BIL level >10ULN
- Associated with HCC
- Patients receiving interferon
- Age under 20
- Judged by investigator not to be appropriate for inclusion in this study
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kinki University School of Medicine, Department of Gastroenterology and Hepatology
Ōsaka-sayama, Osaka, 589-8511
Masatoshi Kudo, professor, +81-72-366-0221 ext. 3149, m-kudo@med.kindai.ac.jp
Kazuomi Ueshima, lecturer, +81-72-366-0221 ext. 3525, kaz-ues@med.kindai.ac.jp
About this study
The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk patients for hepatocarcinogenesis,Furthermore, to analyze whether early detection of HCC by CE-US has a survival benefit than that by B-mode US.
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis, Hepatitis B, Hepatitis C
- Being tested
- CE-US (Sonazoid™), B-mode US
- Keywords
- Sonazoid, Early detection, Hepatocellular carcinoma, Liver cirrhosis
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis, Hepatitis B, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE-US (Sonazoid™)Device
Also called Sonazoid Group
screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
B-mode USDevice
Also called B-mode Group
screening by conventional B-mode US every 3-5 months
| Study group | Role | What they receive |
|---|---|---|
| Group of CE-US | Active comparator | screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months Receives: Device: CE-US (Sonazoid™) |
| Group of B-mode US | Active comparator | screening by conventional B-mode US every 3-5 months Receives: Device: B-mode US |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of HCC which is detected first
Measured: 10 years
Secondary outcomes (2)
Time to detection of HCC
Measured: 10 years
The improvement of prognosis of patients who are diagnosed in this study
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kindai University
- Sponsor type
- University, hospital or other
- Investigators
- Masatoshi Kudo, professor, Principal investigator, Kindai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822991
- Sponsor's protocol ID
- JLOG08001
- Other IDs
- UMIN000001612
- Status last verified
- Jan 2009
- First submitted
- 14 Jan 2009
- Last updated
- 30 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kudo M, Hatanaka K, Kumada T, Toyoda H, Tada T. Double-contrast ultrasound: a novel surveillance tool for hepatocellular carcinoma. Am J Gastroenterol. 2011 Feb;106(2):368-70. doi: 10.1038/ajg.2010.432. No abstract available.
PubMed 21301463
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonazoid Enhanced Liver Cancer Trial for Early Detection
- ClinicalTrials.gov ID
- NCT00822991
- Acronym / sponsor ID
- JLOG08001
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis, Hepatitis B, Hepatitis C
- Keywords
- Sonazoid, Early detection, Hepatocellular carcinoma, Liver cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Kindai UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Jan 2009 (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.
The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk patients for hepatocarcinogenesis,Furthermore, to analyze whether early detection of HCC by CE-US has a survival benefit than that by B-mode US.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of CE-US | Active comparator | Device: CE-US (Sonazoid™)screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months |
| Group of B-mode US | Active comparator | Device: B-mode USscreening by conventional B-mode US every 3-5 months |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 20
- HBV or HCV related liver cirrhosis
- No history of HCC
- Diagnosed as liver cirrhosis histologically or clinically Histologically confirmed by liver biopsy Confirmed by formula of diagnosing cirrhosis Radiological finding Finding of portal hypertension Platelet<130,000
- Inpatient or outpatient
Key exclusion criteria (7 listed)
- History of hypersensitivity to egg yolk
- Pregnant or lactating women and women who may be pregnant
- Severe liver dysfunction(AST, ALT,or BIL level >10ULN
- Associated with HCC
- Patients receiving interferon
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 |
|---|---|---|
| CE-US (Sonazoid™)Also: Sonazoid Groupscreening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months | Device | Group of CE-US |
| B-mode USAlso: B-mode Groupscreening by conventional B-mode US every 3-5 months | Device | Group of B-mode US |
Primary outcome
Size of HCC which is detected first
Time frame: 10 years
2 secondary outcomes
Time to detection of HCC
Time frame: 10 years
The improvement of prognosis of patients who are diagnosed in this study
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2010.
- Derived from this study: PubMed 21301463Kudo M, Hatanaka K, Kumada T, Toyoda H, Tada T. Double-contrast ultrasound: a novel surveillance tool for hepatocellular carcinoma. Am J Gastroenterol. 2011 Feb;106(2):368-70. doi: 10.1038/ajg.2010.432. No abstract available.
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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.
Masatoshi Kudo, professor principal investigator
Kindai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CE-US (Sonazoid™) and B-mode US in people with Hepatocellular Carcinoma and Liver Cirrhosis, run by Kindai University at 1 site in Japan.
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 7 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 30 Dec 2010. 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 Japan. 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 Masatoshi Kudo, professor (+81-72-366-0221 ext. 3149, m-kudo@med.kindai.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of HCC which is detected first (time frame: 10 years). 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 NCT00822991, 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 30 Dec 2010.