Superb Microvascular Imaging in Focal Nodular Hyperplasia

"The Fingerprint: Spoke-wheel Sign" of Focal Nodular Hyperplasia: Assessment of Novel Ultrasound Approach Using Superb Microvascular Imaging Technique

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.)

Study Overview

• Status: Completed
• Conditions: Focal Nodular Hyperplasia
• Intervention / Treatment: Drug: Sonazoid; Device: Superb-Microvascular imaging

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Drug: Sonazoid; Sonazoid: Commercially available contrast material for ultrasonography; Other Names: Perfluorobutane; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Woo Kyoung Woo, M.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): April 25, 2019
• Study Completion (Actual): April 25, 2019

Study Registration Dates

• First Submitted: January 15, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 15, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasonography; Focal nodular hyperplasia; Superb-Microvascular imaging; Contrast-enhanced ultrasonography
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Hyperplasia; Focal Nodular Hyperplasia
• Other Study ID Numbers: 2015-10-134-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No