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Superb Microvascular Imaging in Focal Nodular Hyperplasia

NCT ID: NCT02737865

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-04-25

Brief Summary

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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.)

Detailed Description

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1. To evaluate the detection rate of 'spoke-wheel sign' on CEUS using sonazoid and SMI (primary outcome).

Each US findings during exam for patients with FNH were recorded by radiologist. The results were interpreted by consensus using 4 scale bar.

0\. Absence of 'spoke-wheel sign'
1. Mild suspicious of 'spoke-wheel sign'
2. Highly suspicious of 'spoke-wheel sign'
3. Definite "spoke-wheel sign'
2. To evaluated the accuracy of size measurement for FNH on gray-scale US and SMI (reference standard: CEUS using sonazoid).

To calculate the measurement error between each method and CEUS using sonazoid on US images using measurement of maximum diameter of tumor.
3. Sample size calculation according to the primary outcome.

Expecting the detection rate of "spoke-wheel sign" on SMI, 20% (known detection rate on CEUS using sonazoid, 23.5%), a sample size of 62 patients was required using 95% confidence interval.

Conditions

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Focal Nodular Hyperplasia

Keywords

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Focal nodular hyperplasia Ultrasonography Superb-Microvascular imaging Contrast-enhanced ultrasonography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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SMI and sonazoid (single arm)

Patients with focal nodular hyperplasia will undergo ultrasonography with Superb-Microvascular imaging and additional sonazoid-enhanced ultrasonography. SMI is a software function in a Toshiba Aplio 500 system. Sonazoid is contrast-material for US and it is a intervention for patient with FNH. Sonazoid will be administered at a dose of 0.015 mL/kg by manual bolus injection, followed by a 10 mL normal saline flush via a peripheral venous line

Group Type EXPERIMENTAL

Sonazoid

Intervention Type DRUG

Sonazoid: Commercially available contrast material for ultrasonography

Superb-Microvascular imaging

Intervention Type DEVICE

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

Interventions

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Sonazoid

Sonazoid: Commercially available contrast material for ultrasonography

Intervention Type DRUG

Superb-Microvascular imaging

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

Intervention Type DEVICE

Other Intervention Names

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Perfluorobutane

Eligibility Criteria

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Inclusion Criteria

1\. Patients with biopsy or imaging proven focal nodular hyperplasia

Exclusion Criteria

1. Pregnant women
2. Patient's age \> 70
3. Egg allergy
4. Breast-feeding women
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Woo Kyoung Jeong, MD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Woo Kyoung Woo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2015-10-134-003

Identifier Type: -

Identifier Source: org_study_id