Hepatocellular CancerNCT04212273
Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC
A study testing Diagnostic Sonazoid-CEUS and EOB-MRI in people with Hepatocellular Cancer and Liver Cirrhoses, run by Tianjin Third Central Hospital at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) is the fifth most common cancer. Patients with HCCs usually have a poor prognosis. Hepatocarcinogenesis is an intricate and multistep process. Detecting and staging early HCC in patients with liver cirrhosis are still challenging for imaging techniques. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Cancer, Liver Cirrhoses, Diagnoses Disease
- What is being tested?
- Diagnostic Sonazoid-CEUS and EOB-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2019to 24 Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are at high risk for HCC.
- The ages of patients are between 18 and 80.
- Patients are with solid liver lesion(s) detected by US: if a patient has a solitary tumor, the size of the tumor is less than or equal to 5 cm; if a patient has multiple lesions, the sizes of the tumors are less than or equal to 3 cm and the number of lesions is less than or equal to 3.
- Patient is able and willing to receive CEUS and EOB-MRI examinations within 30 days.
- Patient signs the informed consent. -
Who cannot join
- Patient is with lesions confirmed by pathology or follow-up, or hemangiomas.
- Patient is with lesions already undergoing local treatment, including thermal ablation or TACE.
- Patient is with severe cardiopulmonary insufficiency.
- Patient is a pregnant or breastfeeding women.
- Patient is considered to be unsuitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300170
Xiang Jing, MD, 02284112323 ext. +86, dr.jingxiang@aliyun.com
About this study
Official title: A Single-center, Prospective Controlled Study of the Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC
Hepatocellular carcinoma (HCC) is the fifth most common cancer. Patients with HCCs usually have a poor prognosis. Hepatocarcinogenesis is an intricate and multistep process. Detecting and staging early HCC in patients with liver cirrhosis are still challenging for imaging techniques. Contrast-enhanced ultrasonography (CEUS) and gadoxetic acid-enhanced magnetic resonance imaging (EOB-MRI) are widely used in clinical practice. EOB-MRI has advantages of high detecting rate for small lesions, high sensitivity of hepatobiliary phase and extensive image information. Sonazoid has the advantage of offering a unique post-vascular phase, also called the Kupffer phase. Therefore, malignant tumors with few or no Kupffer cells appear as contrast defects, with respect to the relatively well-enhanced surrounding liver in the postvascular phase. The diagnostic efficacies of these two imaging methods have not been well studied. Therefore, the purpose of this study is to compare the efficacies of Sonazoid-CEUS and EOB-MRI in patients with high risk of HCC, and to compare the detection ability for malignant tumors by Kupffer phase and hepatobiliary phase.
- Conditions
- Hepatocellular Cancer, Liver Cirrhoses, Diagnoses Disease
- Being tested
- Diagnostic Sonazoid-CEUS and EOB-MRI
- Keywords
- Hepatocellular carcinoma, Sonazoid Contrast-enhanced ultrasound, EOB-MRI, Diagnostic Efficacy
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Sonazoid-CEUS and EOB-MRIDiagnostic test
Undergo Sonazoid-CEUS and EOB-MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Sonazoid-CEUS and EOB-MRI | Experimental | Patients with high risk of HCC having suspicious lesions on US will receive Sonazoid-CEUS and EOB-MRI examinations. Receives: Diagnostic Test: Diagnostic Sonazoid-CEUS and EOB-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI
The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI in the diagnosis for patients with high risk of HCC will be determined.
Measured: 6 to 12 months
Secondary outcomes (1)
The detection rate of the additionally found HCC
The detection rate of the additionally found HCC on Sonazoid-CEUS and EOB-MRI will be determined .
Measured: 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start21 Dec 2019
- Primary completion24 Dec 2022 (estimated)
- Study completion24 Dec 2022 (estimated)
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 CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Third Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiang Jing, MD, Study director, Tianjin Third Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212273
- Sponsor's protocol ID
- drjingxiang001
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2019
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
European Association for the Study of the Liver. Corrigendum to "EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma" [J Hepatol 69 (2018) 182-236]. J Hepatol. 2019 Apr;70(4):817. doi: 10.1016/j.jhep.2019.01.020. Epub 2019 Feb 7. No abstract available.
PubMed 30739718Omata M, Cheng AL, Kokudo N, Kudo M, Lee JM, Jia J, Tateishi R, Han KH, Chawla YK, Shiina S, Jafri W, Payawal DA, Ohki T, Ogasawara S, Chen PJ, Lesmana CRA, Lesmana LA, Gani RA, Obi S, Dokmeci AK, Sarin SK. Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update. Hepatol Int. 2017 Jul;11(4):317-370. doi: 10.1007/s12072-017-9799-9. Epub 2017 Jun 15.
PubMed 28620797
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective Controlled Study of the Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC
- ClinicalTrials.gov ID
- NCT04212273
- Acronym / sponsor ID
- drjingxiang001
- Conditions
- Hepatocellular Cancer, Liver Cirrhoses, Diagnoses Disease
- Keywords
- Hepatocellular carcinoma, Sonazoid Contrast-enhanced ultrasound, EOB-MRI, Diagnostic Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Third Central HospitalUniversity, hospital or other
- Study start
- 21 Dec 2019 (actual)
- Primary completion
- 24 Dec 2022 (estimated)
- Study completion
- 24 Dec 2022 (estimated)
- First posted
- 26 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.
Hepatocellular carcinoma (HCC) is the fifth most common cancer. Patients with HCCs usually have a poor prognosis. Hepatocarcinogenesis is an intricate and multistep process. Detecting and staging early HCC in patients with liver cirrhosis are still challenging for imaging techniques. Contrast-enhanced ultrasonography (CEUS) and gadoxetic acid-enhanced magnetic resonance imaging (EOB-MRI) are widely used in clinical practice. EOB-MRI has advantages of high detecting rate for small lesions, high sensitivity of hepatobiliary phase and extensive image information. Sonazoid has the advantage of offering a unique post-vascular phase, also called the Kupffer phase. Therefore, malignant tumors with few or no Kupffer cells appear as contrast defects, with respect to the relatively well-enhanced surrounding liver in the postvascular phase. The diagnostic efficacies of these two imaging methods have not been well studied. Therefore, the purpose of this study is to compare the efficacies of Sonazoid-CEUS and EOB-MRI in patients with high risk of HCC, and to compare the detection ability for malignant tumors by Kupffer phase and hepatobiliary phase.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Sonazoid-CEUS and EOB-MRI | Experimental | Diagnostic Test: Diagnostic Sonazoid-CEUS and EOB-MRIPatients with high risk of HCC having suspicious lesions on US will receive Sonazoid-CEUS and EOB-MRI examinations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are at high risk for HCC.
- The ages of patients are between 18 and 80.
- Patients are with solid liver lesion(s) detected by US: if a patient has a solitary tumor, the size of the tumor is less than or equal to 5 cm; if a patient has multiple lesions, the sizes of the tumors are less than or equal to 3 cm and the number of lesions is less than or equal to 3.
- Patient is able and willing to receive CEUS and EOB-MRI examinations within 30 days.
- Patient signs the informed consent. -
Key exclusion criteria (5 listed)
- Patient is with lesions confirmed by pathology or follow-up, or hemangiomas.
- Patient is with lesions already undergoing local treatment, including thermal ablation or TACE.
- Patient is with severe cardiopulmonary insufficiency.
- Patient is a pregnant or breastfeeding women.
- Patient is considered to be unsuitable to participate in the 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 |
|---|---|---|
| Diagnostic Sonazoid-CEUS and EOB-MRIUndergo Sonazoid-CEUS and EOB-MRI | Diagnostic test | Diagnostic Sonazoid-CEUS and EOB-MRI |
Primary outcome
The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI
Time frame: 6 to 12 months
The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI in the diagnosis for patients with high risk of HCC will be determined.
1 secondary outcome
The detection rate of the additionally found HCC
Time frame: 6 to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Background: PubMed 30739718European Association for the Study of the Liver. Corrigendum to "EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma" [J Hepatol 69 (2018) 182-236]. J Hepatol. 2019 Apr;70(4):817. doi: 10.1016/j.jhep.2019.01.020. Epub 2019 Feb 7. No abstract available.
- Background: PubMed 28620797Omata M, Cheng AL, Kokudo N, Kudo M, Lee JM, Jia J, Tateishi R, Han KH, Chawla YK, Shiina S, Jafri W, Payawal DA, Ohki T, Ogasawara S, Chen PJ, Lesmana CRA, Lesmana LA, Gani RA, Obi S, Dokmeci AK, Sarin SK. Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update. Hepatol Int. 2017 Jul;11(4):317-370. doi: 10.1007/s12072-017-9799-9. Epub 2017 Jun 15.
- HCC diagnosis guidelineLink provided by the sponsor.
- HCC diagnosis guidelineLink provided by the sponsor.
- EOB-MRILink provided by the sponsor.
- 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.
Xiang Jing, MD study director
Tianjin Third Central 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 Diagnostic Sonazoid-CEUS and EOB-MRI in people with Hepatocellular Cancer and Liver Cirrhoses, run by Tianjin Third Central Hospital at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 13 Dec 2022. 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 China. 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 Xiang Jing, MD (02284112323 ext. +86, dr.jingxiang@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI (time frame: 6 to 12 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 NCT04212273, 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 13 Dec 2022.