Focal Nodular HyperplasiaNCT02737865
Superb Microvascular Imaging in Focal Nodular Hyperplasia
A study testing Sonazoid and Superb-Microvascular imaging in people with Focal Nodular Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Focal Nodular Hyperplasia
- What is being tested?
- Sonazoid and Superb-Microvascular imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to 25 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with biopsy or imaging proven focal nodular hyperplasia
Who cannot join
- Pregnant women
- Patient's age > 70
- Egg allergy
- Breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "The Fingerprint: Spoke-wheel Sign" of Focal Nodular Hyperplasia: Assessment of Novel Ultrasound Approach Using Superb Microvascular Imaging Technique
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.)
Read the detailed description
- 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.
- Conditions
- Focal Nodular Hyperplasia
- Being tested
- Sonazoid, Superb-Microvascular imaging
- Keywords
- Focal nodular hyperplasia, Ultrasonography, Superb-Microvascular imaging, Contrast-enhanced ultrasonography
- Medical subject headings
- Focal Nodular Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonazoidDrug
Also called Perfluorobutane
Sonazoid: Commercially available contrast material for ultrasonography
Superb-Microvascular imagingDevice
Superb-Microvascular imaging: new sonographic software technique on ultrasonography to detect low-vascular flow without use of contrast media for ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| SMI and sonazoid (single arm) | Experimental | 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 Receives: Drug: Sonazoid; Device: Superb-Microvascular imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Absence of 'spoke-wheel sign'
- Mild suspicious of 'spoke-wheel sign'
- Highly suspicious of 'spoke-wheel sign'
- Definite "spoke-wheel sign'
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMay 2016
- Primary completion25 Apr 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Nodular HyperplasiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Kyoung Jeong, MD, Samsung Medical Center
- Investigators
- Woo Kyoung Woo, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737865
- Sponsor's protocol ID
- 2015-10-134-003
- Status last verified
- Dec 2019
- First submitted
- 15 Jan 2016
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Fingerprint: Spoke-wheel Sign" of Focal Nodular Hyperplasia: Assessment of Novel Ultrasound Approach Using Superb Microvascular Imaging Technique
- ClinicalTrials.gov ID
- NCT02737865
- Acronym / sponsor ID
- 2015-10-134-003
- Conditions
- Focal Nodular Hyperplasia
- Keywords
- Focal nodular hyperplasia, Ultrasonography, Superb-Microvascular imaging, Contrast-enhanced ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMI and sonazoid (single arm) | Experimental | Drug: Sonazoid, Device: Superb-Microvascular imagingPatients 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients with biopsy or imaging proven focal nodular hyperplasia
Key exclusion criteria (4 listed)
- Pregnant women
- Patient's age > 70
- Egg allergy
- Breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonazoidAlso: PerfluorobutaneSonazoid: Commercially available contrast material for ultrasonography | Drug | SMI and sonazoid (single arm) |
| Superb-Microvascular imagingSuperb-Microvascular imaging: new sonographic software technique on ultrasonography to detect low-vascular flow without use of contrast media for ultrasonography | Device | SMI and sonazoid (single arm) |
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'
1 secondary outcome
Measurement error of focal nodular hyperplasia between b-mode US and SMI according to the reference standard, CEUS
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: No. Undecided
Related trials for Focal Nodular Hyperplasia
Not yet recruiting
Pragmatic RCT of AI-Assisted Reading for Malignant Hepatic Lesions on CE-CT
Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc)
Not yet recruitingObservational study
Application of Super-Resolution Ultrasound (SRUS) in Liver Tumor
Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocellular Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woo Kyoung Woo, M.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonazoid and Superb-Microvascular imaging in people with Focal Nodular Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading of spoke-wheel sign on CEUS using sonazoid and SMI in patients with focal nodular hyperplasia (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.