Clinical trial NCT02737865: 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
Overall status: COMPLETED
Phase: NA
Conditions: Focal Nodular Hyperplasia
Keywords: Focal nodular hyperplasia
Ultrasonography
Superb-Microvascular imaging
Contrast-enhanced ultrasonography
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Grading of spoke-wheel sign on CEUS using sonazoid and SMI in patients with focal nodular hyperplasia
timeFrame: 1 day
Secondary outcomes:
measure: Measurement error of focal nodular hyperplasia between b-mode US and SMI according to the reference standard, CEUS
timeFrame: 1 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Woo Kyoung Woo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: