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Liver LesionsPhase 3NCT03335566

An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging

A Phase 3 study testing Sonazoid™ and SonoVue® in people with Liver Lesions, run by GE Healthcare at 18 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the efficacy of Sonazoid™ and SonoVue® in participants with focal liver lesions (FLLs), by comparing pre-and post-contrast ultrasound examination findings with regard to various aspects of lesion diagnosis including diagnosis as benign versus malignant, specific lesion… Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Liver Lesions
What is being tested?
Sonazoid™ and SonoVue®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
18 sitesin 3 countries
Study dates
11 May 2014to 9 Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • The participant has an acute clinically fatal condition (i.e., not expected to survive for at least 6 months)
  • The participant has previously received Sonazoid™ or has received SonoVue® within the past 30 days
  • The participant has undergone or is undergoing systemic or loco-regional chemotherapy, or radiation therapy
  • The participant is participating in another clinical trial with an unregistered medicinal product, or less than 30 days have passed since completing participation in such a trial
  • The participant has a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension or shock)
  • The participant has known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue®
Show all 13Show fewer
  • The participant has undergone or plans to undergo liver biopsy or surgery within the 24 hours before or after this examination
  • The participant has undergone or plans to undergo an examination with a contrast agent (i.e., iodinated x-ray contrast agent, magnetic resonance imaging (MRI) contrast agent or another ultrasound contrast agent) within the 24 hours before or after this examination
  • The participant is considered to be unsuitable to participate in the study by the investigator
  • The participant is known to have a right-to-left shunt, severe pulmonary hypertension (pulmonary artery pressure >90 millimeter of mercury (mmHg) or uncontrolled systemic hypertension
  • The participant has a recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within the last 7 days, significant worsening of cardiac symptoms within the last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of electrocardiogram [ECG], laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders
  • The participant has adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
  • The participant has known thrombosis within the liver, portal, or mesenteric veins

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

China11 sites

  • Peking Union Medical College Hospital, East Campus: No.1 Shuaifuyuan Wangfujing

    Dongcheng, Beijing Municipality, 100730

  • The First Affiliated Hospital, Sun-Yat sen University, No. 58 Zhongshan Second Road

    Guangzhou, Guangdong, 510080

  • The Second Affiliated Hospital of Zhongshan University, No. 107 Yanjiang West Road

    Guangzhou, Guangdong, 510120

  • Chinese PLA General Hospital, No. 28 Fuxing Road

    Haidan, Beijing Municipality, 100853

  • Shanghai First Hospital, North Campus: No. 100 Haining Road

    Hongkou, Shanghai Municipality, 200080

  • Shanghai First Hospital, South Campus: No.650 New Songjiang Road

    Songjiang, Shanghai Municipality, 201620

  • Peking Union Medical College Hospital, West Campus: No. 41 Damucang Hutong

    Xicheng, Beijing Municipality, 100032

  • Zhongshan Hospital Fudan University, No. 180 Fenglin Road

    Xuhui, Shanghai Municipality, 200032

  • Shanghai Hua Shan Hospital, No. 12 Wulumuqi Middle Road

    Xuhui, Shanghai Municipality, 200040

  • Shanghai Sixth Hospital, No. 600 Yishan Road

    Xuhui, Shanghai Municipality, 200233

  • Shanghai Tenth People's Hospital, No. 301 Yanchang Middle Road

    Zhabei, Shanghai Municipality, 200072

Other trials in China

Taiwan5 sites

  • National Taiwan University Hospital - Yunlin Branch, No. 579, Sec. 2 Yunlin Road

    Douliu, Yunlin County

  • National Taiwan University Hospital, No. 7 Chung-Shan South Road

    Taipei, 100

  • Mackay Memorial Hospital, No. 92, Sec. 2 Zhongshan N. Road

    Taipei, 10449

  • Cathay General Hospital, No. 280 Jen-Ai Road, Sec. 4

    Taipei, 10650

  • Taipei Veterans General Hospital, No. 201 Shih-Pai Road, Sec. 2

    Taipei, 112

Other trials in Taiwan

South Korea2 sites

  • Seoul National University Hospital, 101, Daehak-Ro, Jongno-Gu

    Seoul, 110-744

  • Seoul St Mary's Hospital, 222 Banpo-daero, Seocho-gu

    Seoul, 137-701

Other trials in South Korea

About this study

Official title: A Phase 3 Multicentre, Randomised, Comparative Study of the Efficacy and Safety of the Ultrasound Contrast Agents Sonazoid™ and SonoVue® in Subjects With Focal Liver Lesions Undergoing Pre- and Post-Contrast Ultrasound Imaging

The purpose of this study is to compare the efficacy of Sonazoid™ and SonoVue® in participants with focal liver lesions (FLLs), by comparing pre-and post-contrast ultrasound examination findings with regard to various aspects of lesion diagnosis including diagnosis as benign versus malignant, specific lesion diagnosis, confidence in diagnosis, and quality of delineation of lesion-related blood vessels (from images obtained during vascular imaging) and detection of lesion presence and quality of delineation of the whole liver (from images obtained during whole liver imaging).

Conditions
Liver Lesions
Being tested
Sonazoid™, SonoVue®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sonazoid™Drug

    Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection.

  • SonoVue®Drug

    Single Dose of SonoVue® 2.4 mL as I.V. injection.

Study groups in NCT03335566
Study groupRoleWhat they receive
Sonazoid™ExperimentalParticipants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight.
Receives: Drug: Sonazoid™
SonoVue®Active comparatorParticipants will receive single I.V bolus injection of SonoVue® 2.4 milliliter (mL).
Receives: Drug: SonoVue®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Accuracy Improvement in Post-Contrast Versus Pre-Contrast Ultrasound (US) Examination for Diagnosis of the Target Lesion as Malignant or Benign Against the Reference Diagnosis (RD)/Standard of Truth

    Accuracy improvement was calculated by the number of participants with improved diagnoses from the pre-contrast diagnosis to the post-contrast diagnosis divided by the total number of participants, multiplied by 100. Assessments were done by 3 blinded readers. Efficacy population which included all participants who received Sonazoid™ or SonoVue®, for whom pre-contrast \& post-contrast images were recorded, \& for whom there was a reference standard contrast-enhanced computed tomography (CECT)/contrast-enhanced magnetic resonance imaging (CE-MRI) examination or biopsy.

    Measured: Pre-administration up to 15 minutes post-administration

Secondary outcomes (3)

  1. Number of Lesions Detected by Post-Contrast US Relative to Number of Lesions Detected by Pre-Contrast US (Both by Blinded Readers[BR]) and Number of Lesions Detected by Post-Contrast US (by BR) Relative to Number of Lesions Detected by RD (Investigators)

    For the cases that can be assessed by the blinded readers both pre- and post-contrast, differences were calculated between the Sonazoid™ and SonoVue® groups in the number of lesions detected during whole-liver imaging (post-contrast minus pre-contrast). The differences were also calculated between the Sonazoid™ and SonoVue® groups in the number of lesions (post-contrast minus reference diagnosis) detected during whole-liver imaging.

    Measured: Pre-administration up to 15 minutes post-administration

  2. Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results

    Confidence in diagnoses from the pre- and post-contrast ultrasound examinations was evaluated based on 4-point scale: 0-Unknown (cannot make a judgement on level of confidence), 1- Not confident (another examination was required), 2- Probable (Would have more confidence if another diagnostic imaging test such as MRI or CT was performed), 3- Definite (Sufficient confidence to the extent that another diagnostic imaging test such as MRI or CT was unnecessary).

    Measured: Pre-administration up to 15 minutes post-administration

  3. Percentage of Participants With Accuracy Improvement in Post-contrast Versus Pre-contrast Ultrasound Examination for Lesion-Specific Diagnoses of the Target Lesion Against the Reference Diagnosis/Standard of Truth

    The accuracy improvement was calculated by the number of participants with improved diagnoses from the pre-contrast diagnosis to the post-contrast diagnosis divided by the total number of participants, multiplied by 100. Assessment was performed by 3 blinded readers.

    Measured: Pre-administration up to 15 minutes post-administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2017
  2. Study start11 May 2014
  3. Primary completion9 Apr 2015
  4. Study completion9 Apr 2015

Resources

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 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03335566
Sponsor's protocol ID
GE-045-002
Other IDs
GE-045-002
Status last verified
Oct 2018
First submitted
3 Nov 2017
Last updated
31 Oct 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sonazoid™ and SonoVue® in people with Liver Lesions, run by GE Healthcare at 18 sites in 3 countries.

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 0 inclusion and 13 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 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China, Taiwan, 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Accuracy Improvement in Post-Contrast Versus Pre-Contrast Ultrasound (US) Examination for Diagnosis of the Target Lesion as Malignant or Benign Against the Reference Diagnosis (RD)/Standard of Truth (time frame: Pre-administration up to 15 minutes post-administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03335566.

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 31 Oct 2018.

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