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

December 11, 2022 updated by: Tianjin Third Central Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300170
        • Recruiting
        • Tianjin Third Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI
Time Frame: 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.
6 to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The detection rate of the additionally found HCC
Time Frame: 6 to 12 months
The detection rate of the additionally found HCC on Sonazoid-CEUS and EOB-MRI will be determined .
6 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Third Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2019

Primary Completion (Anticipated)

December 24, 2022

Study Completion (Anticipated)

December 24, 2022

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 11, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • drjingxiang001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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