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

Diagnoses Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04212286
• Other study ID #: drjingxiang002
• Status: Completed
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: June 28, 2021

Study information

• Verified date: March 2022
• Source: Tianjin Third Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 28, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Diagnoses Disease
• Hepatocellular Cancer
• Liver Cirrhoses
• Liver Cirrhosis
• Liver Neoplasms

Intervention

Diagnostic Test:
• Diagnostic CEUS and EOB-MRI
Undergo Sonovue-CEUS and EOB-MRI

Locations

Country	Name	City	State
China	Tianjin Third Central Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Third Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 to 12 months