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

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ClinicalTrials.gov Identifier: NCT03335566
Recruitment Status : Completed
First Posted : November 7, 2017
Results First Posted : August 27, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Liver Lesions
Interventions Drug: Sonazoid™
Drug: SonoVue®
Enrollment 424
Recruitment Details The study was conducted at 17 centres in China, Korea and Taiwan. A total of 424 participants were enrolled between 11 May 2014 and 9 April 2015.
Pre-assignment Details Participants were randomised in 1:1 ratio to receive either Sonazoid™ or SonoVue®.
Arm/Group Title Sonazoid™ SonoVue®
Hide Arm/Group Description Participants received single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight. Participants received single I.V bolus injection of SonoVue® 2.4 milliliter (mL).
Period Title: Overall Study
Started 218 206
Completed 214 203
Not Completed 4 3
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             1             0
Technical Problems             1             0
Protocol Violation             1             0
Other than specified above             1             2
Arm/Group Title Sonazoid™ SonoVue® Total
Hide Arm/Group Description Participants received single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight. Participants received single I.V bolus injection of SonoVue® 2.4 milliliter (mL). Total of all reporting groups
Overall Number of Baseline Participants 218 206 424
Hide Baseline Analysis Population Description
Analysis was performed on safety analysis set that included all enrolled participants who received either Sonazoid™ or SonoVue.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants 206 participants 424 participants
54.5  (12.61) 52.2  (13.77) 53.4  (13.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 206 participants 424 participants
Female 81 81 162
Male 137 125 262
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 206 participants 424 participants
American Indian or Alaska Native 0 0 0
Asian 218 206 424
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 0 0
White 0 0 0
More than one race 0 0 0
Unknown or Not Reported 0 0 0
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Pre-administration up to 15 minutes post-administration
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.
Arm/Group Title Sonazoid™ SonoVue®
Hide Arm/Group Description:
Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.
Participants received single I.V bolus injection of SonoVue® 2.4 mL.
Overall Number of Participants Analyzed 169 169
Measure Type: Number
Unit of Measure: percentage of participants
Reader 1 Number Analyzed 160 participants 157 participants
18.1 24.2
Reader 2 Number Analyzed 163 participants 158 participants
22.1 14.6
Reader 3 Number Analyzed 165 participants 162 participants
17.0 16.7
2.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Pre-administration up to 15 minutes post-administration
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.
Arm/Group Title Sonazoid™ SonoVue®
Hide Arm/Group Description:
Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.
Participants received single I.V bolus injection of SonoVue® 2.4 mL.
Overall Number of Participants Analyzed 169 169
Median (Inter-Quartile Range)
Unit of Measure: Lesions
Post-contrast minus Pre-contrast: Reader 1 Number Analyzed 161 participants 83 participants
0.0
(-1.0 to 1.0)
0.0
(-1.0 to 0.0)
Post-contrast minus Pre-contrast: Reader 2 Number Analyzed 165 participants 72 participants
0.0
(-2.0 to 0.0)
-1.0
(-2.0 to 0.0)
Post-contrast minus Pre-contrast: Reader 3 Number Analyzed 162 participants 47 participants
0.0
(-1.0 to 0.0)
-1.0
(-2.0 to 0.0)
Post-contrast minus Reference: Reader 1 Number Analyzed 160 participants 83 participants
1.0
(0.0 to 2.0)
1.0
(0.0 to 1.0)
Post-contrast minus Reference: Reader 2 Number Analyzed 162 participants 72 participants
0.0
(0.0 to 1.0)
0.0
(0.0 to 0.0)
Post-contrast minus Reference: Reader 3 Number Analyzed 159 participants 47 participants
0.0
(0.0 to 1.0)
0.0
(-1.0 to 1.0)
3.Secondary Outcome
Title Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results
Hide Description 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).
Time Frame Pre-administration up to 15 minutes post-administration
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.
Arm/Group Title Sonazoid™ SonoVue®
Hide Arm/Group Description:
Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.
Participants received single I.V bolus injection of SonoVue® 2.4 mL.
Overall Number of Participants Analyzed 169 169
Measure Type: Count of Participants
Unit of Measure: Participants
Reader 1: Pre-contrast Number Analyzed 169 participants 169 participants
Definite (3 points)
10
   5.9%
11
   6.5%
Probable (2 points)
113
  66.9%
122
  72.2%
Not confident (1 point)
46
  27.2%
36
  21.3%
Unknown (0 points)
0
   0.0%
0
   0.0%
Reader 1: Post Contrast Number Analyzed 160 participants 157 participants
Definite (3 points)
57
  35.6%
54
  34.4%
Probable (2 points)
86
  53.8%
88
  56.1%
Not confident (1 point)
17
  10.6%
15
   9.6%
Unknown (0 points)
0
   0.0%
0
   0.0%
Reader 2: Pre-contrast Number Analyzed 169 participants 169 participants
Definite (3 points)
15
   8.9%
12
   7.1%
Probable (2 points)
89
  52.7%
79
  46.7%
Not confident (1 point)
65
  38.5%
78
  46.2%
Unknown (0 points)
0
   0.0%
0
   0.0%
Reader 2: Post-contrast Number Analyzed 163 participants 158 participants
Definite (3 points)
116
  71.2%
103
  65.2%
Probable (2 points)
43
  26.4%
51
  32.3%
Not confident (1 point)
4
   2.5%
4
   2.5%
Unknown (0 points)
0
   0.0%
0
   0.0%
Reader 3: Pre-contrast Number Analyzed 169 participants 169 participants
Definite (3 points)
38
  22.5%
36
  21.3%
Probable (2 points)
89
  52.7%
90
  53.3%
Not confident (1 point)
42
  24.9%
42
  24.9%
Unknown (0 points)
0
   0.0%
1
   0.6%
Reader 3: Post-contrast Number Analyzed 165 participants 162 participants
Definite (3 points)
130
  78.8%
117
  72.2%
Probable (2 points)
31
  18.8%
36
  22.2%
Not confident (1 point)
4
   2.4%
9
   5.6%
Unknown (0 points)
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Pre-administration up to 15 minutes post-administration
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.
Arm/Group Title Sonazoid™ SonoVue®
Hide Arm/Group Description:
Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.
Participants received single I.V bolus injection of SonoVue® 2.4 mL.
Overall Number of Participants Analyzed 169 169
Measure Type: Number
Unit of Measure: percentage of participants
Reader 1 Number Analyzed 160 participants 157 participants
11.9 21.7
Reader 2 Number Analyzed 163 participants 158 participants
16.6 15.2
Reader 3 Number Analyzed 165 participants 162 participants
15.8 19.1
Time Frame All Adverse Events (AEs) were collected from administration of investigational medicinal product (IMP) up to the 72 hours post injection regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened any time during or after administration of IMP. Analysis was performed on safety population which included all enrolled participants who received either Sonazoid™ or SonoVue®.
 
Arm/Group Title Sonazoid™ SonoVue®
Hide Arm/Group Description Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight. Participants received single I.V bolus injection of SonoVue® 2.4 mL.
All-Cause Mortality
Sonazoid™ SonoVue®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/218 (0.00%)   0/206 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sonazoid™ SonoVue®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/218 (0.00%)   0/206 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sonazoid™ SonoVue®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/218 (0.00%)   0/206 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
Results Point of Contact
Name/Title: Francois Tranquart, M.D, PhD
Organization: GE Healthcare
Phone: 011-44-1494-543037
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT03335566     History of Changes
Other Study ID Numbers: GE-045-002
GE-045-002 ( Other Identifier: GE HealthCare )
First Submitted: November 3, 2017
First Posted: November 7, 2017
Results First Submitted: December 13, 2017
Results First Posted: August 27, 2018
Last Update Posted: October 31, 2018