Liver CancerNCT05360420
Diagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure
A study testing Immediate CEUS in people with Liver Cancer and Liver Cirrhosis, run by Tianjin Third Central Hospital at 1 site in China.
Trial summary
Due to different etiologies, diagnosis and treatment of HCC in China is different from that in Western countries.US is an important screening method for HCC in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer, Liver Cirrhosis
- What is being tested?
- Immediate CEUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,730 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2022to 31 Dec 2024
- 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 US.
- Patient signs the informed consent.
Who cannot join
- Patients are with liver cirrhosis due to congenital hepatic fibrosis or due to hepatic vascular diseases such as hereditary telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion syndrome, congestive heart disease.
- Patient's age is < 18 years old or > 80 years old.
- Patients with known hypersensitivity to CEUS, CECT, CEMRI, or hepatobiliary-specific MRI contrast agents.
- Patient is a pregnant or breastfeeding woman.
- Patient is not diagnosed based on the reference diagnostic criteria required by the study.
- 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
Yan Zhou, MD, 02284118101 ext. +86, zhouyan2626@163.com
About this study
Official title: Screening and Diagnosis of Nodules ≤2 cm in High-risk HCC Patients in China Based on US and CEUS: a Multicenter, Prospective, Randomized Controlled Study
Due to different etiologies, diagnosis and treatment of HCC in China is different from that in Western countries.US is an important screening method for HCC in patients with liver cirrhosis. CEUS, as an enhanced imaging method based on US, has the advantages of convenience, non-radiation, low cost, short examination time, and the diagnostic performance of HCC is comparable to that of CECT, CEMRI, and hepatobiliary-specific MRI.
It is of great significance to consider the cost-effectiveness of each examination based on the principle of cost minimization. Therefore, we propose immediate CEUS examination for suspicious lesions ≤2 cm screened by US, and determine the diagnostic process of further diagnostic methods based on the CEUS results. The aim of this study is to establish a screening and diagnosis process for HCC ≤2 cm suitable for China considering time effect, economic effect and diagnostic efficiency.
- Conditions
- Liver Cancer, Liver Cirrhosis
- Being tested
- Immediate CEUS
- Keywords
- Liver Cancer, CEUS, Diagnostic Methods, Cost Optimization
- Medical subject headings
- Liver Neoplasms, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate CEUSDiagnostic test
Subjects will receive CEUS examination immediately for the suspicious lesion detected by US.
| Study group | Role | What they receive |
|---|---|---|
| Immediate CEUS group | Experimental | CEUS (SonoVue) was performed immediately after routine US screening of suspicious lesions. The lesions were classified according to CEUS examination by the diagnosing physician, including consideration of HCC, suspected HCC, and benign lesions. Further hepatobiliary-specific MRI (Modis/Primexian) was performed for lesions considered HCC or suspicious for HCC, and benign lesions were followed up. The diagnostic findings of hepatobiliary-specific MRI were classified by the diagnosing physician and included consideration of HCC, suspected HCC, and benign lesions. For hepatobiliary-specific MRI lesions considered HCC or suspicious for HCC, pathological examination was performed, and benign lesions were followed up. Receives: Diagnostic Test: Immediate CEUS |
| Current clinical procedure group | No intervention | After the suspicious lesions were screened by routine US, CECT, CEMRI and hepatobiliary-specific MRI (the first enhanced imaging examination) were independently selected by clinicians. According to the first examination results of the contrast-enhanced image, the diagnosis was classified by the diagnosing physician, including considering HCC, suspicious HCC, and benign lesions. Another contrast-enhanced imaging examination (CECT or CEMRI or hepatobiliary-specific MRI or CEUS) was performed again for lesions considered or suspected of HCC (second contrast-enhanced imaging study), and negative lesions were followed up. According to the examination results of the second enhanced imaging, the classification includes considering HCC, suspicious HCC, and benign. Pathological examination was performed for lesions considered HCC or suspicious for HCC on the second enhanced image, and benign lesions were followed up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance based on US and immediate CEUS with current routine
The diagnostic efficacy，including sensitivity, specificity, accurary and AUC， of the two groups for HCC from the detection of suspicious lesions by routine US screening to the final diagnosis.
Measured: 6 to 12 months
Time benefits based on US and immediate CEUS with current routine
Time from the detection of suspicious lesions by routine US screening to the first diagnosis of HCC by enhanced imaging examinations and the final diagnosis of HCC.
Measured: 6 to 12 months
Secondary outcomes (1)
The economic benefit based on US and immediate CEUS with current routine
The cost of imaging studies from the discovery of suspicious lesions by routine US screening to the final clinical diagnosis of HCC or the clinical diagnosis of benign lesions.
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 posted4 May 2022
- Study start26 Oct 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Third Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Second People's Hospital, Tianjin Medical University Cancer Institute and Hospital, Peking University Binhai Hospital, Tianjin Nankai Hospital, Tianjin Medical University Second Hospital, Tianjin Medical University General Hospital, China-Japan Friendship Hospital, Beijing Hospital, Shanxi Province Cancer Hospital, Shanxi Provincial People's Hospital, The First Affiliated Hospital of Shanxi Medical University, Second Hospital of Shanxi Medical University, Shengjing Hospital, Hebei General Hospital, First Affiliated Hospital of Harbin Medical University, The Third Affiliated Hospital of Harbin Medical University
- Responsible party
- Sponsor
- Investigators
- Xiang Jing, MD, Study director, Tianjin Third Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360420
- Sponsor's protocol ID
- drjingxiang004
- Status last verified
- Dec 2022
- First submitted
- 4 Mar 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Screening and Diagnosis of Nodules ≤2 cm in High-risk HCC Patients in China Based on US and CEUS: a Multicenter, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05360420
- Acronym / sponsor ID
- drjingxiang004
- Conditions
- Liver Cancer, Liver Cirrhosis
- Keywords
- Liver Cancer, CEUS, Diagnostic Methods, Cost Optimization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,730 participants (estimated)
- Lead sponsor
- Tianjin Third Central HospitalUniversity, hospital or other
- Collaborators
- Tianjin Second People's Hospital, Tianjin Medical University Cancer Institute and Hospital, Peking University Binhai Hospital, Tianjin Nankai Hospital, Tianjin Medical University Second Hospital, Tianjin Medical University General Hospital, China-Japan Friendship Hospital, Beijing Hospital, Shanxi Province Cancer Hospital, Shanxi Provincial People's Hospital, The First Affiliated Hospital of Shanxi Medical University, Second Hospital of Shanxi Medical University, Shengjing Hospital, Hebei General Hospital, First Affiliated Hospital of Harbin Medical University, The Third Affiliated Hospital of Harbin Medical University
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 May 2022 (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.
Due to different etiologies, diagnosis and treatment of HCC in China is different from that in Western countries.US is an important screening method for HCC in patients with liver cirrhosis. CEUS, as an enhanced imaging method based on US, has the advantages of convenience, non-radiation, low cost, short examination time, and the diagnostic performance of HCC is comparable to that of CECT, CEMRI, and hepatobiliary-specific MRI.
It is of great significance to consider the cost-effectiveness of each examination based on the principle of cost minimization. Therefore, we propose immediate CEUS examination for suspicious lesions ≤2 cm screened by US, and determine the diagnostic process of further diagnostic methods based on the CEUS results. The aim of this study is to establish a screening and diagnosis process for HCC ≤2 cm suitable for China considering time effect, economic effect and diagnostic efficiency.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate CEUS group | Experimental | Diagnostic Test: Immediate CEUSCEUS (SonoVue) was performed immediately after routine US screening of suspicious lesions. The lesions were classified according to CEUS examination by the diagnosing physician, including consideration of HCC, suspected HCC, and benign lesions. Further hepatobiliary-specific MRI (Modis/Primexian) was performed for lesions considered HCC or suspicious for HCC, and benign lesions were followed up. The diagnostic findings of hepatobiliary-specific MRI were classified by the diagnosing physician and included consideration of HCC, suspected HCC, and benign lesions. For hepatobiliary-specific MRI lesions considered HCC or suspicious for HCC, pathological examination was performed, and benign lesions were followed up. |
| Current clinical procedure group | No intervention | –After the suspicious lesions were screened by routine US, CECT, CEMRI and hepatobiliary-specific MRI (the first enhanced imaging examination) were independently selected by clinicians. According to the first examination results of the contrast-enhanced image, the diagnosis was classified by the diagnosing physician, including considering HCC, suspicious HCC, and benign lesions. Another contrast-enhanced imaging examination (CECT or CEMRI or hepatobiliary-specific MRI or CEUS) was performed again for lesions considered or suspected of HCC (second contrast-enhanced imaging study), and negative lesions were followed up. According to the examination results of the second enhanced imaging, the classification includes considering HCC, suspicious HCC, and benign. Pathological examination was performed for lesions considered HCC or suspicious for HCC on the second enhanced image, and benign lesions were followed up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 US.
- Patient signs the informed consent.
Key exclusion criteria (6 listed)
- Patients are with liver cirrhosis due to congenital hepatic fibrosis or due to hepatic vascular diseases such as hereditary telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion syndrome, congestive heart disease.
- Patient's age is < 18 years old or > 80 years old.
- Patients with known hypersensitivity to CEUS, CECT, CEMRI, or hepatobiliary-specific MRI contrast agents.
- Patient is a pregnant or breastfeeding woman.
- Patient is not diagnosed based on the reference diagnostic criteria required by 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 |
|---|---|---|
| Immediate CEUSSubjects will receive CEUS examination immediately for the suspicious lesion detected by US. | Diagnostic test | Immediate CEUS group |
Primary outcome
Diagnostic performance based on US and immediate CEUS with current routine
Time frame: 6 to 12 months
The diagnostic efficacy，including sensitivity, specificity, accurary and AUC， of the two groups for HCC from the detection of suspicious lesions by routine US screening to the final diagnosis.
Time benefits based on US and immediate CEUS with current routine
Time frame: 6 to 12 months
Time from the detection of suspicious lesions by routine US screening to the first diagnosis of HCC by enhanced imaging examinations and the final diagnosis of HCC.
1 secondary outcome
The economic benefit based on US and immediate CEUS with current routine
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.
- Individual participant dataSharing planned: No
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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 Immediate CEUS in people with Liver Cancer and Liver Cirrhosis, 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 4 inclusion and 6 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?
Diagnostic performance based on US and immediate CEUS with current routine (time frame: 6 to 12 months). 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?
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.