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Superb Microvascular Imaging in Focal Nodular Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737865
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Woo Kyoung Jeong, MD, Samsung Medical Center

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.)


Condition or disease Intervention/treatment Phase
Focal Nodular Hyperplasia Drug: Sonazoid Device: Superb-Microvascular imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: "The Fingerprint: Spoke-wheel Sign" of Focal Nodular Hyperplasia: Assessment of Novel Ultrasound Approach Using Superb Microvascular Imaging Technique
Study Start Date : May 2016
Actual Primary Completion Date : April 25, 2019
Actual Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  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.

    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'


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737865


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Woo Kyoung Woo, M.D. Samsung Medical Center

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Responsible Party: Woo Kyoung Jeong, MD, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02737865    
Other Study ID Numbers: 2015-10-134-003
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Woo Kyoung Jeong, MD, Samsung Medical Center:
Focal nodular hyperplasia
Ultrasonography
Superb-Microvascular imaging
Contrast-enhanced ultrasonography
Additional relevant MeSH terms:
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Focal Nodular Hyperplasia
Hyperplasia
Pathologic Processes
Liver Diseases
Digestive System Diseases