Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC

Diagnoses Disease Clinical Trial

Official title:

A Single-center, Prospective Controlled Study of the Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212273
• Other study ID #: drjingxiang001
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2019
• Est. completion date: December 24, 2022

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

Hepatocellular carcinoma (HCC) is the fifth most common cancer. Patients with HCCs usually have a poor prognosis. Hepatocarcinogenesis is an intricate and multistep process. Detecting and staging early HCC in patients with liver cirrhosis are still challenging for imaging techniques. Contrast-enhanced ultrasonography (CEUS) and gadoxetic acid-enhanced magnetic resonance imaging (EOB-MRI) are widely used in clinical practice. EOB-MRI has advantages of high detecting rate for small lesions, high sensitivity of hepatobiliary phase and extensive image information. Sonazoid has the advantage of offering a unique post-vascular phase, also called the Kupffer phase. Therefore, malignant tumors with few or no Kupffer cells appear as contrast defects, with respect to the relatively well-enhanced surrounding liver in the postvascular phase. The diagnostic efficacies of these two imaging methods have not been well studied. Therefore, the purpose of this study is to compare the efficacies of Sonazoid-CEUS and EOB-MRI in patients with high risk of HCC, and to compare the detection ability for malignant tumors by Kupffer phase and hepatobiliary phase.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 24, 2022
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients are at high risk for HCC.

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

3. Patients are with solid liver lesion(s) detected by US: if a patient has a solitary tumor, the size of the tumor is less than or equal to 5 cm; if a patient has multiple lesions, the sizes of the tumors are less than or equal to 3 cm and the number of lesions is less than or equal to 3.

4. Patient is able and willing to receive CEUS and EOB-MRI examinations within 30 days.

5. Patient signs the informed consent. -

Exclusion Criteria:

1. Patient is with lesions confirmed by pathology or follow-up, or hemangiomas.

2. Patient is with lesions already undergoing local treatment, including thermal ablation or TACE.

3. Patient is with severe cardiopulmonary insufficiency.

4. Patient is a pregnant or breastfeeding women.

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Diagnoses Disease
• Hepatocellular Cancer
• Liver Cirrhoses
• Liver Cirrhosis
• Liver Neoplasms

Intervention

Diagnostic Test:
• Diagnostic Sonazoid-CEUS and EOB-MRI
Undergo Sonazoid-CEUS and EOB-MRI

Locations

Country	Name	City	State
China	Tianjin Third Central Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Third Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu. Corrigendum to "EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma" [J Hepatol 69 (2018) 182-236]. J Hepatol. 2019 Apr;70(4):817. doi: 10.1016/j.jhep.2019.01.020. Epub 2019 Feb 7. No abstract available. — View Citation

Omata M, Cheng AL, Kokudo N, Kudo M, Lee JM, Jia J, Tateishi R, Han KH, Chawla YK, Shiina S, Jafri W, Payawal DA, Ohki T, Ogasawara S, Chen PJ, Lesmana CRA, Lesmana LA, Gani RA, Obi S, Dokmeci AK, Sarin SK. Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update. Hepatol Int. 2017 Jul;11(4):317-370. doi: 10.1007/s12072-017-9799-9. Epub 2017 Jun 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI	The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI in the diagnosis for patients with high risk of HCC will be determined.	6 to 12 months
Secondary	The detection rate of the additionally found HCC	The detection rate of the additionally found HCC on Sonazoid-CEUS and EOB-MRI will be determined .	6 to 12 months

External Links

•   Cancer statistics in China
•   CEUS contrast agents
•   EOB-MRI
•   HCC diagnosis guideline
•   HCC diagnosis guideline
•   Sonazoid contrast agent
•   Sonazoid contrast agent