Liver CancerNCT06590948
Clinical Application of Quantitative Major Imaging Features of CEUS LI-RADS
An observational study of Liver Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Liver cancer (LC) is the sixth most common malignant tumor and the third cause of cancer mortality in the world. According to the 2018 United States Association for the Study of Liver Diseases guidelines for the diagnosis and treatment of liver cancer, patients with HCC high-risk factors can be directly diagnosed by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- contrast-enhanced ultrasound
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2024to Jul 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High-risk groups of HCC with pathology results
Who may be able to join
- High-risk groups of HCC: patients with liver cirrhosis or chronic viral hepatitis B, or patients who have been diagnosed with HCC or have a history of HCC in the past, as well as adult liver transplant patients and follow-up patients after liver transplantation;
- CEUS and contrast-enhanced CT/MRI examinations were performed within 2 months before surgery;
- There are clear surgical pathological or puncture pathological results;
- Clinical, imaging, and pathological data are complete
Who cannot join
- Patients who are not suitable for LI-RADS: patients aged 18 years old or liver cirrhosis caused by congenital liver fibrosis or liver cirrhosis due to hepatovascular disease or diffuse regenerative nodules in the liver;
- Those who underwent drug therapy (chemotherapy, immunotherapy, and targeted therapy) or local treatment of target lesions (TACE, radiotherapy, radiofrequency ablation, microwave ablation, etc.);
- The quality of the patient's preoperative image or surgical pathological image is poor or incomplete;
- Those with annular hyperenhancement or marginal nodular hyperenhancement of arterial lesions in contrast-enhanced ultrasound.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Pintong Huang, +8618857168333, huangpintong@126.com
About this study
Official title: Clinical Application of Quantitative Major Imaging Features of Contrast-enhanced Ultrasound Liver Imaging Reporting and Data System
Liver cancer (LC) is the sixth most common malignant tumor and the third cause of cancer mortality in the world. According to the 2018 United States Association for the Study of Liver Diseases guidelines for the diagnosis and treatment of liver cancer, patients with HCC high-risk factors can be directly diagnosed by imaging if they have typical imaging signs, without the need for puncture pathological confirmation.
Since 2011, United States the American College of Radiology (ACR) has successively launched Liver Imaging And Reporting and Data System (LI-RADS) based-on contrast-enhanced CT (CECT), contrast-enhanced MRI (CEMRI), and contrast-enhanced ultrasound (CEUS) , which have achieved good clinical diagnostic results and are constantly being updated and improved.LI-RADS provides standardized imaging diagnosis for high-risk populations and classifies each liver lesion into LR-1 to LR-5 (possibility of HCC), LR-M (probably or definitely malignant, but not HCC), LR-TIV (intravenous tumor).
Read more
Although CEUS LR-5 has a high accuracy in diagnosing HCC, there is also a considerable proportion of HCC in CEUS LR-4 and CEUS LR-3. Studies have shown that CEUS LR-M contains a high proportion of HCC, the sensitivity of CEUS LR-5 in diagnosing HCC is relatively low, and the possibility of HCC cannot be ruled out if it is not classified as CEUS LR-5. Therefore, how to improve the diagnostic sensitivity and specificity is the key goal of CEUS LI-RADS.
According to the CEUS LI-RADS diagnostic criteria, the key signs include arterial phase hyper-enhancement (APHE) and washout. The guidelines divide washout into an early and late washout with 60 seconds after contrast agent injection. If the lesion present with a completely "black hole" within 2 minutes, it is classified as marked washout, otherwise it is mild washout. The current judgment of the degree of washout is based on the subjective decision made by the observer subjectively, which cannot distinguish the subtle differences in the image and has a subjective dependence. The consistency among the observers is uneven, which affects the diagnostic efficiency of CEUS LI-RADS. Based on this, the purpose of this study was to quantify the key parameters of CEUS LI-RADS: Washout Onset and Washout Degree, and propose standardized and objective diagnostic criteria, to reduce the differences between observers and further improve its diagnostic sensitivity for high-risk groups of HCC.
- Conditions
- Liver Cancer
- Being tested
- contrast-enhanced ultrasound
- Keywords
- hepatic carcinoma, contrast-enhanced ultrasound, liver imaging reporting and data system, washout
- 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.
contrast-enhanced ultrasoundDiagnostic test
contrast-enhanced ultrasound with SonoVue and quantitative analysis of liver imaging reporting and data system
| Study group | Role | What they receive |
|---|---|---|
| HCC | Not described Receives: Diagnostic Test: contrast-enhanced ultrasound | |
| non-HCC | Not described Receives: Diagnostic Test: contrast-enhanced ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathology results
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590948
- Sponsor's protocol ID
- 2024-0347
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Quantitative Major Imaging Features of Contrast-enhanced Ultrasound Liver Imaging Reporting and Data System
- ClinicalTrials.gov ID
- NCT06590948
- Acronym / sponsor ID
- 2024-0347
- Conditions
- Liver Cancer
- Keywords
- hepatic carcinoma, contrast-enhanced ultrasound, liver imaging reporting and data system, washout
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Liver cancer (LC) is the sixth most common malignant tumor and the third cause of cancer mortality in the world. According to the 2018 United States Association for the Study of Liver Diseases guidelines for the diagnosis and treatment of liver cancer, patients with HCC high-risk factors can be directly diagnosed by imaging if they have typical imaging signs, without the need for puncture pathological confirmation.
Since 2011, United States the American College of Radiology (ACR) has successively launched Liver Imaging And Reporting and Data System (LI-RADS) based-on contrast-enhanced CT (CECT), contrast-enhanced MRI (CEMRI), and contrast-enhanced ultrasound (CEUS) , which have achieved good clinical diagnostic results and are constantly being updated and improved.LI-RADS provides standardized imaging diagnosis for high-risk populations and classifies each liver lesion into LR-1 to LR-5 (possibility of HCC), LR-M (probably or definitely malignant, but not HCC), LR-TIV (intravenous tumor).
Although CEUS LR-5 has a high accuracy in diagnosing HCC, there is also a considerable proportion of HCC in CEUS LR-4 and CEUS LR-3. Studies have shown that CEUS LR-M contains a high proportion of HCC, the sensitivity of CEUS LR-5 in diagnosing HCC is relatively low, and the possibility of HCC cannot be ruled out if it is not classified as CEUS LR-5. Therefore, how to improve the diagnostic sensitivity and specificity is the key goal of CEUS LI-RADS.
According to the CEUS LI-RADS diagnostic criteria, the key signs include arterial phase hyper-enhancement (APHE) and washout. The guidelines divide washout into an early and late washout with 60 seconds after contrast agent injection. If the lesion present with a completely "black hole" within 2 minutes, it is classified as marked washout, otherwise it is mild washout. The current judgment of the degree of washout is based on the subjective decision made by the observer subjectively, which cannot distinguish the subtle differences in the image and has a subjective dependence. The consistency among the observers is uneven, which affects the diagnostic efficiency of CEUS LI-RADS. Based on this, the purpose of this study was to quantify the key parameters of CEUS LI-RADS: Washout Onset and Washout Degree, and propose standardized and objective diagnostic criteria, to reduce the differences between observers and further improve its diagnostic sensitivity for high-risk groups of HCC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC | – | Diagnostic Test: contrast-enhanced ultrasound |
| non-HCC | – | Diagnostic Test: contrast-enhanced ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High-risk groups of HCC with pathology results
Key inclusion criteria (4 listed)
- High-risk groups of HCC: patients with liver cirrhosis or chronic viral hepatitis B, or patients who have been diagnosed with HCC or have a history of HCC in the past, as well as adult liver transplant patients and follow-up patients after liver transplantation;
- CEUS and contrast-enhanced CT/MRI examinations were performed within 2 months before surgery;
- There are clear surgical pathological or puncture pathological results;
- Clinical, imaging, and pathological data are complete
Key exclusion criteria (4 listed)
- Patients who are not suitable for LI-RADS: patients aged 18 years old or liver cirrhosis caused by congenital liver fibrosis or liver cirrhosis due to hepatovascular disease or diffuse regenerative nodules in the liver;
- Those who underwent drug therapy (chemotherapy, immunotherapy, and targeted therapy) or local treatment of target lesions (TACE, radiotherapy, radiofrequency ablation, microwave ablation, etc.);
- The quality of the patient's preoperative image or surgical pathological image is poor or incomplete;
- Those with annular hyperenhancement or marginal nodular hyperenhancement of arterial lesions in contrast-enhanced ultrasound.
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 |
|---|---|---|
| contrast-enhanced ultrasoundcontrast-enhanced ultrasound with SonoVue and quantitative analysis of liver imaging reporting and data system | Diagnostic test | HCC, non-HCC |
Primary outcome
pathology results
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 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 19 Sep 2024. 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 Yang Sun, Mrs. (18768197675, 1025407867@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathology results (time frame: 2 months). 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 19 Sep 2024.