Clinical Trial: Superb Microvascular Imaging in Focal Nodular Hyperplasia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

  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.


Sponsor: Samsung Medical Center

Current Primary Outcome: Grading of spoke-wheel sign on CEUS using sonazoid and SMI in patients with focal nodular hyperplasia [ Time Frame: 1 day ]

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'


Original Primary Outcome: Same as current

Current Secondary Outcome: Measurement error of focal nodular hyperplasia between b-mode US and SMI according to the reference standard, CEUS [ Time Frame: 1 day ]

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.


Original Secondary Outcome: Same as current

Information By: Samsung Medical Center

Dates:
Date Received: January 15, 2016
Date Started: May 2016
Date Completion: May 2018
Last Updated: May 22, 2016
Last Verified: May 2016