Hepatocellular CancerNCT04212286
Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC
A study testing Diagnostic 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
HCC is a serious threat to the health of people. Accurate diagnosis of early HCC by imaging allows patients to obtain proper treatment. However, for lesions with diameters ≤2 cm, the tumor blood supply is not fully established, and there may be no typical manifestation on the image. 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 CEUS and EOB-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2019to 28 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are at high risk of HCC.
- The ages of patients are between 18 and 80.
- Patients are with solid liver lesion(s) ≤ 2 cm detected by imaging scan (US/CT/MRI).
- 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
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300170
About this study
Official title: A Single-Center, Prospective Study Comparing the Diagnostic Efficiencies of Contrast-Enhanced Ultrasound and EOB Contrast-Enhanced Magnetic Resonance Imaging for Lesions With Diameters ≤ 2cm in Patients With High Risk of HCC
HCC is a serious threat to the health of people. Accurate diagnosis of early HCC by imaging allows patients to obtain proper treatment. However, for lesions with diameters ≤2 cm, the tumor blood supply is not fully established, and there may be no typical manifestation on the image. In addition, atypical enhanced patterns caused by liver cirrhosis may also hinder imaging diagnosis of HCC. Therefore, early diagnosis of HCC in the context of cirrhosis remains a major clinical problem.
Contrast-enhanced Ultrasound (CEUS) and MRI Contrast-enhanced Magnetic Resonance Imaging (CEMRI) are common diagnostic imaging methods. Till now, there is still lack of a detailed investigation comparing the diagnostic efficacies of CEUS and EOB-MRI for micro HCC in the context of cirrhosis. Therefore, this study aims to analyze the imaging patterns in CEUS and EOB-MRI for liver lesions with diameters ≤ 2 cm among patients with high risk of HCC, and to compare the diagnostic efficacies of EOB-MRI and CEUS for early-stage HCCs.
- Conditions
- Hepatocellular Cancer, Liver Cirrhoses, Diagnoses Disease
- Being tested
- Diagnostic CEUS and EOB-MRI
- Keywords
- Hepatocellular Cancer, Contrast-enhanced ultrasound, EOB-MRI, Diagnostic Efficacy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic CEUS and EOB-MRIDiagnostic test
Undergo Sonovue-CEUS and EOB-MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic CEUS and EOB-MRI | Experimental | Patients with high risk of HCC having suspicious lesions with Diameters ≤ 2cm will receive CEUS and EOB-MRI examinations. Receives: Diagnostic Test: Diagnostic 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 CEUS and EOB-MRI
The sensitivity, specificity and accuracy of CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.
Measured: 6 to 12 months
Secondary outcomes (1)
The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI
The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.
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 start23 Oct 2019
- Primary completion28 Jun 2021
- Study completion28 Jun 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 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
- 115 participants (actual)
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
- NCT04212286
- Sponsor's protocol ID
- drjingxiang002
- Status last verified
- Mar 2022
- First submitted
- 2 Dec 2019
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qin Z, Zhou Y, Zhang X, Ding J, Zhou H, Wang Y, Zhao L, Chen C, Jing X. The comparison of contrast-enhanced ultrasound and gadoxetate disodium-enhanced MRI LI-RADS for nodules </=2 cm in patients at high risk for HCC: a prospective study. Front Oncol. 2024 May 7;14:1345981. doi: 10.3389/fonc.2024.1345981. eCollection 2024.
PubMed 38774417
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective Study Comparing the Diagnostic Efficiencies of Contrast-Enhanced Ultrasound and EOB Contrast-Enhanced Magnetic Resonance Imaging for Lesions With Diameters ≤ 2cm in Patients With High Risk of HCC
- ClinicalTrials.gov ID
- NCT04212286
- Acronym / sponsor ID
- drjingxiang002
- Conditions
- Hepatocellular Cancer, Liver Cirrhoses, Diagnoses Disease
- Keywords
- Hepatocellular Cancer, Contrast-enhanced ultrasound, EOB-MRI, Diagnostic Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Tianjin Third Central HospitalUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- 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.
HCC is a serious threat to the health of people. Accurate diagnosis of early HCC by imaging allows patients to obtain proper treatment. However, for lesions with diameters ≤2 cm, the tumor blood supply is not fully established, and there may be no typical manifestation on the image. In addition, atypical enhanced patterns caused by liver cirrhosis may also hinder imaging diagnosis of HCC. Therefore, early diagnosis of HCC in the context of cirrhosis remains a major clinical problem.
Contrast-enhanced Ultrasound (CEUS) and MRI Contrast-enhanced Magnetic Resonance Imaging (CEMRI) are common diagnostic imaging methods. Till now, there is still lack of a detailed investigation comparing the diagnostic efficacies of CEUS and EOB-MRI for micro HCC in the context of cirrhosis. Therefore, this study aims to analyze the imaging patterns in CEUS and EOB-MRI for liver lesions with diameters ≤ 2 cm among patients with high risk of HCC, and to compare the diagnostic efficacies of EOB-MRI and CEUS for early-stage HCCs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic CEUS and EOB-MRI | Experimental | Diagnostic Test: Diagnostic CEUS and EOB-MRIPatients with high risk of HCC having suspicious lesions with Diameters ≤ 2cm will receive 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 (6 listed)
- Patients are at high risk of HCC.
- The ages of patients are between 18 and 80.
- Patients are with solid liver lesion(s) ≤ 2 cm detected by imaging scan (US/CT/MRI).
- 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.
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 CEUS and EOB-MRIUndergo Sonovue-CEUS and EOB-MRI | Diagnostic test | Diagnostic CEUS and EOB-MRI |
Primary outcome
The sensitivity, specificity and accuracy of CEUS and EOB-MRI
Time frame: 6 to 12 months
The sensitivity, specificity and accuracy of CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.
1 secondary outcome
The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI
Time frame: 6 to 12 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 Mar 2022.
- Derived from this study: PubMed 38774417Qin Z, Zhou Y, Zhang X, Ding J, Zhou H, Wang Y, Zhao L, Chen C, Jing X. The comparison of contrast-enhanced ultrasound and gadoxetate disodium-enhanced MRI LI-RADS for nodules </=2 cm in patients at high risk for HCC: a prospective study. Front Oncol. 2024 May 7;14:1345981. doi: 10.3389/fonc.2024.1345981. eCollection 2024.
- 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 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 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 7 Mar 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?
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?
The sensitivity, specificity and accuracy of 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 NCT04212286, 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 Mar 2022.