Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC

March 4, 2022 updated by: Tianjin Third Central Hospital

A Single-Center, Prospective Study Comparing the Diagnostic Efficiencies of Contrast-Enhanced Ultrasound and EOB Contrast-Enhanced Magnetic Resonance Imaging for Lesions With Diameters ≤ 2cm in Patients With High Risk of HCC

HCC is a serious threat to the health of people. Accurate diagnosis of early HCC by imaging allows patients to obtain proper treatment. However, for lesions with diameters ≤2 cm, the tumor blood supply is not fully established, and there may be no typical manifestation on the image. In addition, atypical enhanced patterns caused by liver cirrhosis may also hinder imaging diagnosis of HCC. Therefore, early diagnosis of HCC in the context of cirrhosis remains a major clinical problem.

Contrast-enhanced Ultrasound (CEUS) and MRI Contrast-enhanced Magnetic Resonance Imaging (CEMRI) are common diagnostic imaging methods. Till now, there is still lack of a detailed investigation comparing the diagnostic efficacies of CEUS and EOB-MRI for micro HCC in the context of cirrhosis. Therefore, this study aims to analyze the imaging patterns in CEUS and EOB-MRI for liver lesions with diameters ≤ 2 cm among patients with high risk of HCC, and to compare the diagnostic efficacies of EOB-MRI and CEUS for early-stage HCCs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

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 Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300170
        • 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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients are at high risk of HCC.
  2. The ages of patients are between 18 and 80.
  3. Patients are with solid liver lesion(s) ≤ 2 cm detected by imaging scan (US/CT/MRI).
  4. The number of lesions is less than or equal to 3.
  5. Patient is able and willing to receive CEUS and EOB-MRI examinations within 30 days.
  6. 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diagnostic CEUS and EOB-MRI
Patients with high risk of HCC having suspicious lesions with Diameters ≤ 2cm will receive CEUS and EOB-MRI examinations.
Diagnostic test: Diagnostic CEUS and EOB-MRI
Undergo Sonovue-CEUS and EOB-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity, specificity and accuracy of CEUS and EOB-MRI
Time Frame: 6 to 12 months
The sensitivity, specificity and accuracy of CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.
6 to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI
Time Frame: 6 to 12 months
The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.
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

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)

October 23, 2019

Primary Completion (ACTUAL)

June 28, 2021

Study Completion (ACTUAL)

June 28, 2021

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 (ACTUAL)

March 7, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • drjingxiang002

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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