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

NCT04212273 | Unknown

• 1 other identifier: drjingxiang001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Cancer; Liver Cirrhoses; Diagnoses Disease

Keywords

Hepatocellular carcinoma; Sonazoid Contrast-enhanced ultrasound; EOB-MRI; Diagnostic Efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The detection rate of the additionally found HCC

  6 to 12 months

Study Arms (1)

Diagnostic Sonazoid-CEUS and EOB-MRI

EXPERIMENTAL

Patients with high risk of HCC having suspicious lesions on US will receive Sonazoid-CEUS and EOB-MRI examinations.

Diagnostic Test: Diagnostic Sonazoid-CEUS and EOB-MRI

Interventions

Diagnostic Sonazoid-CEUS and EOB-MRI DIAGNOSTIC_TEST

Undergo Sonazoid-CEUS and EOB-MRI

Diagnostic Sonazoid-CEUS and EOB-MRI

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 for HCC.
• The ages of patients are between 18 and 80.
• 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.
• Patient is able and willing to receive CEUS and EOB-MRI examinations within 30 days.
• Patient signs the informed consent. -

You may not qualify if:

• Patient is with lesions confirmed by pathology or follow-up, or hemangiomas.
• Patient is with lesions already undergoing local treatment, including thermal ablation or TACE.
• Patient is with severe cardiopulmonary insufficiency.
• Patient is a pregnant or breastfeeding women.
• Patient is considered to be unsuitable to participate in the study.

Sponsors & Collaborators

• Tianjin Third Central Hospital: lead

Study Sites (1)

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, 300170, China

RECRUITING

Related Publications (2)

• European Association for the Study of the Liver. 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.

  PMID: 30739718 BACKGROUND

• 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.

  PMID: 28620797 BACKGROUND

Related Links

• HCC diagnosis guideline
• HCC diagnosis guideline
• EOB-MRI

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

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

CONTACT

02284118101; zhouyan2626@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 26, 2019
• Study Start: December 21, 2019
• Primary Completion: December 24, 2022
• Study Completion: December 24, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)