NCT05360420

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,730 (estimated)
• Sponsor: Tianjin Third Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cancer
• Liver Cirrhosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Immediate CEUS	Subjects will receive CEUS examination immediately for the suspicious lesion detected by US.

Timeline

• Start date: 2022-10-26
• Primary completion: 2024-01-01
• Completion: 2024-12-31
• First posted: 2022-05-04
• Last updated: 2022-12-13

Locations

1 site across 1 country: China