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

NCT04212286 | Completed

• 1 other identifier: drjingxiang002
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Cancer; Liver Cirrhoses; Diagnoses Disease

Keywords

Hepatocellular Cancer; Contrast-enhanced ultrasound; EOB-MRI; Diagnostic Efficacy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 to 12 months

Secondary Outcomes (1)

• The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI

  6 to 12 months

Study Arms (1)

Diagnostic CEUS and EOB-MRI

EXPERIMENTAL

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

Interventions

Diagnostic CEUS and EOB-MRI DIAGNOSTIC_TEST

Undergo Sonovue-CEUS and EOB-MRI

Diagnostic CEUS and EOB-MRI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Third Central Hospital: lead

Study Sites (1)

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, 300170, China

Location

Related Publications (1)

• 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.

  PMID: 38774417 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Xiang Jing, MD

  Tianjin Third Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 26, 2019
• Study Start: October 23, 2019
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)