Clinical trial NCT05360420: Diagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cancer
Liver Cirrhosis
Keywords: Liver Cancer
CEUS
Diagnostic Methods
Cost Optimization
Lead sponsor: Tianjin Third Central Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Second People's Hospital
name: Tianjin Medical University Cancer Institute and Hospital
name: Peking University Binhai Hospital
name: Tianjin Nankai Hospital
name: Tianjin Medical University Second Hospital
name: Tianjin Medical University General Hospital
name: China-Japan Friendship Hospital
name: Beijing Hospital
name: Shanxi Province Cancer Hospital
name: Shanxi Provincial People's Hospital
name: The First Affiliated Hospital of Shanxi Medical University
name: Second Hospital of Shanxi Medical University
name: Shengjing Hospital
name: Hebei General Hospital
name: First Affiliated Hospital of Harbin Medical University
name: The Third Affiliated Hospital of Harbin Medical University
First posted: 2022-05-04
Enrollment: 6730
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic performance based on US and immediate CEUS with current routine
timeFrame: 6 to 12 months
measure: Time benefits based on US and immediate CEUS with current routine
timeFrame: 6 to 12 months
Secondary outcomes:
measure: The economic benefit based on US and immediate CEUS with current routine
timeFrame: 6 to 12 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Third Central Hospital
name: Xiang Jing, MD
role: STUDY_DIRECTOR
References: