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Completed

NCT Number: NCT02737865

Superb Microvascular Imaging in Focal Nodular Hyperplasia

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.)

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Key information

Conditions

Focal Nodular Hyperplasia Digestive System Diseases Liver Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with biopsy or imaging proven focal nodular hyperplasia

Exclusion criteria

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

Treatment and study plan

Sonazoid

Drug

Sonazoid: Commercially available contrast material for ultrasonography

Other names: Perfluorobutane

Superb-Microvascular imaging

Device

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

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2016
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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