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

Primary Purpose

Hepatocellular Cancer, Liver Cirrhoses, Diagnoses Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Diagnostic CEUS and EOB-MRI
Sponsored by
Tianjin Third Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Cancer focused on measuring Hepatocellular Cancer, Contrast-enhanced ultrasound, EOB-MRI, Diagnostic Efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tianjin Third Central Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic CEUS and EOB-MRI

Arm Description

Patients with high risk of HCC having suspicious lesions with Diameters ≤ 2cm will receive CEUS and EOB-MRI examinations.

Outcomes

Primary Outcome Measures

The sensitivity, specificity and accuracy of CEUS and EOB-MRI
The sensitivity, specificity and accuracy of CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.

Secondary Outcome Measures

The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI
The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.

Full Information

First Posted
December 2, 2019
Last Updated
March 4, 2022
Sponsor
Tianjin Third Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04212286
Brief Title
Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
June 28, 2021 (Actual)
Study Completion Date
June 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Third Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Cancer, Liver Cirrhoses, Diagnoses Disease
Keywords
Hepatocellular Cancer, Contrast-enhanced ultrasound, EOB-MRI, Diagnostic Efficacy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic CEUS and EOB-MRI
Arm Type
Experimental
Arm Description
Patients with high risk of HCC having suspicious lesions with Diameters ≤ 2cm will receive CEUS and EOB-MRI examinations.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic CEUS and EOB-MRI
Intervention Description
Undergo Sonovue-CEUS and EOB-MRI
Primary Outcome Measure Information:
Title
The sensitivity, specificity and accuracy of CEUS and EOB-MRI
Description
The sensitivity, specificity and accuracy of CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.
Time Frame
6 to 12 months
Secondary Outcome Measure Information:
Title
The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI
Description
The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.
Time Frame
6 to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients are at high risk of HCC. The ages of patients are between 18 and 80. Patients are with solid liver lesion(s) ≤ 2 cm detected by imaging scan (US/CT/MRI). 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Jing, MD
Organizational Affiliation
Tianjin Third Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tianjin Third Central Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300170
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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