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

NCT05360420 | Unknown

• 1 other identifier: drjingxiang004
• Study Type: interventional
• Target: 6,730
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Liver Cirrhosis

Keywords

Liver Cancer; CEUS; Diagnostic Methods; Cost Optimization

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• The economic benefit based on US and immediate CEUS with current routine

  6 to 12 months

Study Arms (2)

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.

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.

Interventions

Immediate CEUS DIAGNOSTIC_TEST

Subjects will receive CEUS examination immediately for the suspicious lesion detected by US.

Immediate CEUS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, 300170, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiang Jing, MD

  Tianjin Third Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiang Jing, MD

CONTACT

02284112323; dr.jingxiang@aliyun.com

Yan Zhou, MD

CONTACT

02284118101; zhouyan2626@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: May 4, 2022
• Study Start: October 26, 2022
• Primary Completion: January 1, 2024
• Study Completion: December 31, 2024
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)