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

Not Applicable

Completed

• Conditions: Hepatocellular Cancer; Diagnoses Disease; Liver Cirrhoses
• Interventions: Diagnostic Test: Diagnostic CEUS and EOB-MRI

• Registration Number: NCT04212286
• Lead Sponsor: Tianjin Third Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-23
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-26
• Primary Completion: 2021-06-28
• Study Completion: 2021-06-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The sensitivity, specificity and accuracy of CEUS and EOB-MRI	6 to 12 months	The sensitivity, specificity and accuracy of CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.

Secondary Outcome Measures

Name	Time	Method
The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI	6 to 12 months	The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.

Trial Locations

Locations (1)

Tianjin Third Central Hospital; 🇨🇳 Tianjin, Tianjin, China