Skip to main content
OpenTrials
Completed

NCT Number: NCT04212286

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatocellular Cancer Diagnoses Disease Digestive System Diseases Digestive System Neoplasms Liver Cirrhoses Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, 300170, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic CEUS and EOB-MRI

Diagnostic Test

Undergo Sonovue-CEUS and EOB-MRI

Primary outcomes

  1. The sensitivity, specificity and accuracy of CEUS and EOB-MRI

    Time frame: 6 to 12 months

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

Secondary outcomes

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

    Time frame: 6 to 12 months

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

Sponsors and collaborators

Lead sponsor

Tianjin Third Central Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 26, 2019
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.