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

NCT ID: NCT04212286

Last Updated: 2022-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-23

Study Completion Date

2021-06-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Cancer Liver Cirrhoses Diagnoses Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic CEUS and EOB-MRI

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

Group Type EXPERIMENTAL

Diagnostic CEUS and EOB-MRI

Intervention Type DIAGNOSTIC_TEST

Undergo Sonovue-CEUS and EOB-MRI

Interventions

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Diagnostic CEUS and EOB-MRI

Undergo Sonovue-CEUS and EOB-MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Third Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiang Jing, MD

Role: STUDY_DIRECTOR

Tianjin Third Central Hospital

Locations

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Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

References

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Qin Z, Zhou Y, Zhang X, Ding J, Zhou H, Wang Y, Zhao L, Chen C, Jing X. The comparison of contrast-enhanced ultrasound and gadoxetate disodium-enhanced MRI LI-RADS for nodules </=2 cm in patients at high risk for HCC: a prospective study. Front Oncol. 2024 May 7;14:1345981. doi: 10.3389/fonc.2024.1345981. eCollection 2024.

Reference Type DERIVED
PMID: 38774417 (View on PubMed)

Other Identifiers

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drjingxiang002

Identifier Type: -

Identifier Source: org_study_id

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