Superb Microvascular Imaging in Focal Nodular Hyperplasia

Focal Nodular Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737865
• Other study ID #: 2015-10-134-003
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 25, 2019

Study information

• Verified date: December 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 25, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Focal Nodular Hyperplasia
• Hyperplasia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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