NCT02737865

Brief 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.)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2019

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

3 years

First QC Date

January 15, 2016

Last Update Submit

December 15, 2019

Conditions

Focal Nodular Hyperplasia

Keywords

Focal nodular hyperplasiaUltrasonographySuperb-Microvascular imagingContrast-enhanced ultrasonography

Outcome Measures

Primary Outcomes (1)

  • Grading of spoke-wheel sign on CEUS using sonazoid and SMI in patients with focal nodular hyperplasia

    a.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'

    1 day

Secondary Outcomes (1)

  • Measurement error of focal nodular hyperplasia between b-mode US and SMI according to the reference standard, CEUS

    1 day

Study Arms (1)

SMI and sonazoid (single arm)

EXPERIMENTAL

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

Drug: SonazoidDevice: Superb-Microvascular imaging

Interventions

SonazoidDRUG

Sonazoid: Commercially available contrast material for ultrasonography

Also known as: Perfluorobutane
SMI and sonazoid (single arm)
Superb-Microvascular imagingDEVICE

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

SMI and sonazoid (single arm)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant women
  • Patient's age \> 70
  • Egg allergy
  • Breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Focal Nodular Hyperplasia

Interventions

Sonazoidperfluorobutane

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Woo Kyoung Woo, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 15, 2016

First Posted

April 14, 2016

Study Start

May 1, 2016

Primary Completion

April 25, 2019

Study Completion

April 25, 2019

Last Updated

December 17, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Undecided

Locations

KR(1)