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Superb Microvascular Imaging in Focal Nodular Hyperplasia

NCT02737865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-12-17

No results posted yet for this study

Summary

Focal nodular hyperplasia (FNH) in liver is the second common benign hepatic tumor. It usually shows hypervascular mass on imaging studies and it is not easy to differentiate with other hypervascular malignant tumor. For diagnosis of FNH, contrast-enhanced ultrasonography (US) has been used to detect 'spoke-wheel sign', which can be typically seen in FNH. However, temporal window of vascular phase using contrast-enhanced US (CEUS) is very short (about 10 sec) and coordination of patient's respiration during US exam is absolutely needed. Thus, the investigators will use Superb-Microvascular imaging (SMI, Toshiba, Japan) for detection of 'spoke-wheel sign' in patients with proven FNH, which enable to detect slow micro vascular flow without using CEUS.

First, to compare the detection rate of 'spoke-wheel sign' between CEUS using sonazoid (Perfluorobutane, GE healthcare) and SMI.

Second, to compare the accuracy of size measurement between gray-scale US and SMI (reference standard: CEUS using sonazoid.)

Conditions

  • Focal Nodular Hyperplasia

Interventions

DRUG

Sonazoid

Sonazoid: Commercially available contrast material for ultrasonography

DEVICE

Superb-Microvascular imaging

Superb-Microvascular imaging: new sonographic software technique on ultrasonography to detect low-vascular flow without use of contrast media for ultrasonography

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Woo Kyoung Woo, M.D. · Samsung Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-04-25
Completion
2019-04-25

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02737865 on ClinicalTrials.gov