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Superb Microvascular Imaging in Focal Nodular Hyperplasia

Primary Purpose

Focal Nodular Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sonazoid
Superb-Microvascular imaging
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Focal Nodular Hyperplasia focused on measuring Focal nodular hyperplasia, Ultrasonography, Superb-Microvascular imaging, Contrast-enhanced ultrasonography

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SMI and sonazoid (single arm)

Arm Description

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

Outcomes

Primary Outcome Measures

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' Mild suspicious of 'spoke-wheel sign' Highly suspicious of 'spoke-wheel sign' Definite "spoke-wheel sign'

Secondary Outcome Measures

Measurement error of focal nodular hyperplasia between b-mode US and SMI according to the reference standard, CEUS
To calculate the measurement error between b-mode US and SMI using measurement of maximum diameter of tumor. Reference standard is the size of tumor on sonazoid enhanced US.

Full Information

First Posted
January 15, 2016
Last Updated
December 15, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02737865
Brief Title
Superb Microvascular Imaging in Focal Nodular Hyperplasia
Official Title
"The Fingerprint: Spoke-wheel Sign" of Focal Nodular Hyperplasia: Assessment of Novel Ultrasound Approach Using Superb Microvascular Imaging Technique
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
April 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.)
Detailed Description
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' Mild suspicious of 'spoke-wheel sign' Highly suspicious of 'spoke-wheel sign' Definite "spoke-wheel sign' 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Nodular Hyperplasia
Keywords
Focal nodular hyperplasia, Ultrasonography, Superb-Microvascular imaging, Contrast-enhanced ultrasonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMI and sonazoid (single arm)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sonazoid
Other Intervention Name(s)
Perfluorobutane
Intervention Description
Sonazoid: Commercially available contrast material for ultrasonography
Intervention Type
Device
Intervention Name(s)
Superb-Microvascular imaging
Intervention Description
Superb-Microvascular imaging: new sonographic software technique on ultrasonography to detect low-vascular flow without use of contrast media for ultrasonography
Primary Outcome Measure Information:
Title
Grading of spoke-wheel sign on CEUS using sonazoid and SMI in patients with focal nodular hyperplasia
Description
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' Mild suspicious of 'spoke-wheel sign' Highly suspicious of 'spoke-wheel sign' Definite "spoke-wheel sign'
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Measurement error of focal nodular hyperplasia between b-mode US and SMI according to the reference standard, CEUS
Description
To calculate the measurement error between b-mode US and SMI using measurement of maximum diameter of tumor. Reference standard is the size of tumor on sonazoid enhanced US.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Patients with biopsy or imaging proven focal nodular hyperplasia Exclusion Criteria: Pregnant women Patient's age > 70 Egg allergy Breast-feeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Kyoung Woo, M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Undecided

Learn more about this trial

Superb Microvascular Imaging in Focal Nodular Hyperplasia

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