Clinical trial NCT04212273: Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Cancer
Liver Cirrhoses
Diagnoses Disease
Keywords: Hepatocellular carcinoma
Sonazoid Contrast-enhanced ultrasound
EOB-MRI
Diagnostic Efficacy
Lead sponsor: Tianjin Third Central Hospital
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI
timeFrame: 6 to 12 months
Secondary outcomes:
measure: The detection rate of the additionally found HCC
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:
citation: 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.
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.