Role of CEUS as a Secondary Diagnostic Modality

NCT04494022 | Unknown

• 1 other identifier: 2004-035-1116
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the role of contrast-enhanced ultrasound (CEUS) as a second-line imaging modality after gadoxetate-enhanced MRI (Gd-EOB-MRI) for identifying hepatocellular carcinoma (HCC) among at-risks observations.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation

  Compared the frequency of arterial phase hyperenhancement (APHE) and washout in at-risk observation, between CEUS and Gd-EOB-MRI.

  1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.

• Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.

  Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or Gd-EOB-MRI with CEUS.

  1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.

Secondary Outcomes (1)

• Comparing image characters between two types of ultrasound contrast media

  For 3 days after undergoing CEUS to check the complication of CEUS, per each participants.

Study Arms (2)

Cross-sectional image only

NO INTERVENTION

Image set which consists of a Cross-sectional image only.

Cross-sectional image with CEUS

ACTIVE COMPARATOR

The same participants with Arm1. But image set will consist of a Cross-sectional image and CEUS.

Diagnostic Test: contrast enhanced ultrasound

Interventions

contrast enhanced ultrasound DIAGNOSTIC_TEST

Perflubutane enhanced ultrasound for evaluating hepatic tumor

Cross-sectional image with CEUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at risk of HCC by Liver Imaging Reporting and Data System (LI-RADS)
• at least one treatment-naïve solid hepatic observation (≥1 cm) while surveillance using US, CT or MRI
• signed informed consent

You may not qualify if:

• congestive hepatopathies
• severe cardiovascular dysfunction
• no recent cross-sectional images within 4 weeks
• suboptimal cross-sectional images quality

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jeong Min Lee, M.D.

  Seoul National University

  STUDY DIRECTOR

Central Study Contacts

Hyo-Jin Kang, M.D.

CONTACT

82220723107; dr.kanghj@gmail.com

Hyun-Hee Lee, B.S.

CONTACT

82220723107; redlion55@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pf.

Model Details: All participants underwent CEUS. The image reviews based on cross-section images will be performed with or without CEUS results. Two image sets (cross-sectional image with CEUS and without CEUS) will be compared.

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: July 31, 2020
• Study Start: June 8, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: For two years after publication.
• Access Criteria: except you want to use illegal purpose

Locations

KR (1)