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

• Sponsor: Tianjin Third Central Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04212273
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Cancer; Liver Cirrhoses; Diagnoses Disease	Diagnostic Test: Diagnostic Sonazoid-CEUS and EOB-MRI	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Anticipated Study Start Date: Dec 24, 2019
• Anticipated Primary Completion Date: Dec 24, 2021
• Anticipated Study Completion Date: Dec 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diagnostic Sonazoid-CEUS and EOB-MRI 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; Undergo Sonazoid-CEUS and EOB-MRI

Outcome Measures

Primary Outcome Measures

1. The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI [6 to 12 months]

   The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI in the diagnosis for patients with high risk of HCC will be determined.

Secondary Outcome Measures

1. The detection rate of the additionally found HCC [6 to 12 months]

   The detection rate of the additionally found HCC on Sonazoid-CEUS and EOB-MRI will be determined .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Third Central Hospital	Tianjin	Tianjin	China	300170

Sponsors and Collaborators

• Tianjin Third Central Hospital

Investigators

• Study Director: Xiang Jing, MD, Tianjin Third Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

• European Association for the Study of the Liver. Electronic address: [e-mail]. 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.
• 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. Review.

• Responsible Party: Tianjin Third Central Hospital
• ClinicalTrials.gov Identifier: NCT04212273
• Other Study ID Numbers: drjingxiang001
• First Posted: Dec 26, 2019
• Last Update Posted: Dec 26, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tianjin Third Central Hospital: Hepatocellular carcinoma; Sonazoid Contrast-enhanced ultrasound; EOB-MRI; Diagnostic Efficacy
• Additional relevant MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular; Liver Cirrhosis

Study Results

No Results Posted as of Dec 26, 2019