Diagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure

Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05360420
• Other study ID #: drjingxiang004
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Tianjin Third Central Hospital
• Contact: Xiang Jing, MD
• Phone: 02284112323
• Email: dr.jingxiang[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6730
• Est. completion date: December 31, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients are at high risk of HCC.

2. The ages of patients are between 18 and 80.

3. Patients are with solid liver lesion(s) = 2 cm detected by US.

4. Patient signs the informed consent.

Exclusion Criteria:

1. 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.

2. Patient's age is < 18 years old or > 80 years old.

3. Patients with known hypersensitivity to CEUS, CECT, CEMRI, or hepatobiliary-specific MRI contrast agents.

4. Patient is a pregnant or breastfeeding woman.

5. Patient is not diagnosed based on the reference diagnostic criteria required by the study.

6. Patient is considered to be unsuitable to participate in the study.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Cirrhosis
• Liver Neoplasms

Intervention

Diagnostic Test:
• Immediate CEUS
Subjects will receive CEUS examination immediately for the suspicious lesion detected by US.

Locations

Country	Name	City	State
China	Tianjin Third Central Hospital	Tianjin	Tianjin

Sponsors (17)

Lead Sponsor

Collaborator

Tianjin Third Central Hospital

Beijing Hospital, China-Japan Friendship Hospital, First Affiliated Hospital of Harbin Medical University, Hebei General Hospital, Peking University Binhai Hospital, Second Hospital of Shanxi Medical University, Shanxi Province Cancer Hospital, Shanxi Provincial People's Hospital, Shengjing Hospital, The First Affiliated Hospital of Shanxi Medical University, The Third Affiliated Hospital of Harbin Medical University, Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University General Hospital, Tianjin Medical University Second Hospital, Tianjin Nankai Hospital, Tianjin Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 to 12 months
Primary	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.	6 to 12 months
Secondary	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.	6 to 12 months