Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-27 @ 5:14 AM
Study NCT ID:
NCT03335566
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2017-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C069727', 'term': 'Sonazoid'}, {'id': 'C420843', 'term': 'contrast agent BR1'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'francois.tranquart@ge.com', 'phone': '011-44-1494-543037', 'title': 'Francois Tranquart, M.D, PhD', 'organization': 'GE Healthcare'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '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.', '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®.', 'eventGroups': [{'id': 'EG000', 'title': 'Sonazoid™', 'description': 'Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.', 'otherNumAtRisk': 218, 'deathsNumAtRisk': 218, 'otherNumAffected': 0, 'seriousNumAtRisk': 218, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SonoVue®', 'description': 'Participants received single I.V bolus injection of SonoVue® 2.4 mL.', 'otherNumAtRisk': 206, 'deathsNumAtRisk': 206, 'otherNumAffected': 0, 'seriousNumAtRisk': 206, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sonazoid™', 'description': 'Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.'}, {'id': 'OG001', 'title': 'SonoVue®', 'description': 'Participants received single I.V bolus injection of SonoVue® 2.4 mL.'}], 'classes': [{'title': 'Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-administration up to 15 minutes post-administration', '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.'}, {'type': 'SECONDARY', '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)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sonazoid™', 'description': 'Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.'}, {'id': 'OG001', 'title': 'SonoVue®', 'description': 'Participants received single I.V bolus injection of SonoVue® 2.4 mL.'}], 'classes': [{'title': 'Post-contrast minus Pre-contrast: Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '0.0'}]}]}, {'title': 'Post-contrast minus Pre-contrast: Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '0.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '0.0'}]}]}, {'title': 'Post-contrast minus Pre-contrast: Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '0.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '0.0'}]}]}, {'title': 'Post-contrast minus Reference: Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Post-contrast minus Reference: Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Post-contrast minus Reference: Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-administration up to 15 minutes post-administration', '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.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sonazoid™', 'description': 'Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.'}, {'id': 'OG001', 'title': 'SonoVue®', 'description': 'Participants received single I.V bolus injection of SonoVue® 2.4 mL.'}], 'classes': [{'title': 'Reader 1: Pre-contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Definite (3 points)', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Probable (2 points)', 'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}, {'title': 'Not confident (1 point)', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Unknown (0 points)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reader 1: Post Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Definite (3 points)', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}, {'title': 'Probable (2 points)', 'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}, {'title': 'Not confident (1 point)', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Unknown (0 points)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2: Pre-contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Definite (3 points)', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Probable (2 points)', 'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'title': 'Not confident (1 point)', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}, {'title': 'Unknown (0 points)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2: Post-contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Definite (3 points)', 'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}, {'title': 'Probable (2 points)', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': 'Not confident (1 point)', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Unknown (0 points)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3: Pre-contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Definite (3 points)', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Probable (2 points)', 'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}, {'title': 'Not confident (1 point)', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Unknown (0 points)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3: Post-contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Definite (3 points)', 'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}, {'title': 'Probable (2 points)', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Not confident (1 point)', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Unknown (0 points)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-administration up to 15 minutes post-administration', '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).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.'}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sonazoid™', 'description': 'Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.'}, {'id': 'OG001', 'title': 'SonoVue®', 'description': 'Participants received single I.V bolus injection of SonoVue® 2.4 mL.'}], 'classes': [{'title': 'Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}]}]}, {'title': 'Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-administration up to 15 minutes post-administration', '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sonazoid™', 'description': 'Participants received single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight.'}, {'id': 'FG001', 'title': 'SonoVue®', 'description': 'Participants received single I.V bolus injection of SonoVue® 2.4 milliliter (mL).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '206'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Technical Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'Participants were randomised in 1:1 ratio to receive either Sonazoid™ or SonoVue®.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sonazoid™', 'description': 'Participants received single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight.'}, {'id': 'BG001', 'title': 'SonoVue®', 'description': 'Participants received single I.V bolus injection of SonoVue® 2.4 milliliter (mL).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '12.61', 'groupId': 'BG000'}, {'value': '52.2', 'spread': '13.77', 'groupId': 'BG001'}, {'value': '53.4', 'spread': '13.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on safety analysis set that included all enrolled participants who received either Sonazoid™ or SonoVue.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 424}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2015-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2017-11-03', 'resultsFirstSubmitDate': '2017-12-13', 'studyFirstSubmitQcDate': '2017-11-03', 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-13', 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Pre-administration up to 15 minutes post-administration', '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.'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': 'Pre-administration up to 15 minutes post-administration', '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.'}, {'measure': 'Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results', 'timeFrame': 'Pre-administration up to 15 minutes post-administration', '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).'}, {'measure': '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', 'timeFrame': 'Pre-administration up to 15 minutes post-administration', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Lesions']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Participants may be included in the study if they meet all of the following criteria:\n\n* Participant has at least 1 untreated focal liver lesions (FLL) but =\\<8 lesions (excluding cysts) \\<10 centimeter (cm) in diameter confirmed in a diagnostic examination performed in the past month (or past 3 months if lesion is benign) that can be visualised by non- contrast-enhanced (CE) ultrasound\n* Participant has had a dynamic CE-computed tomography (CE-CT) or CE-magnetic resonance imaging (CE-MRI) examination within the past month or is scheduled to have one in the month following inclusion in the study and the original images (or copies thereof) are/will be available. (This inclusion criterion does not apply for participants enrolled as training cases. Investigators will be asked to submit standard of truth/ reference diagnosis for training cases whenever possible, since the cases may be used for training and testing the blinded readers prior to the blinded read)\n* Participant is a 20- to 80-year-old inpatient or outpatient referred for an ultrasound examination of the liver\n* Participant is able and willing to comply with study procedures and will give their signed and dated informed consent\n* The participant, if female, is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum or urine human chorionic gonadotropin pregnancy test, performed on the day of investigational medicinal product (IMP) administration (with the result known before IMP administration), are negative\n\nExclusion Criteria:\n\n* The participant has an acute clinically fatal condition (i.e., not expected to survive for at least 6 months)\n* The participant has previously received Sonazoid™ or has received SonoVue® within the past 30 days\n* The participant has undergone or is undergoing systemic or loco-regional chemotherapy, or radiation therapy\n* 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\n* 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)\n* The participant has known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue®\n* The participant has undergone or plans to undergo liver biopsy or surgery within the 24 hours before or after this examination\n* 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\n* The participant is considered to be unsuitable to participate in the study by the investigator\n* 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\n* 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\n* The participant has adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli\n* The participant has known thrombosis within the liver, portal, or mesenteric veins'}, 'identificationModule': {'nctId': 'NCT03335566', 'briefTitle': 'An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GE-045-002'}, 'secondaryIdInfos': [{'id': 'GE-045-002', 'type': 'OTHER', 'domain': 'GE HealthCare'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sonazoid™', 'description': 'Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight.', 'interventionNames': ['Drug: Sonazoid™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SonoVue®', 'description': 'Participants will receive single I.V bolus injection of SonoVue® 2.4 milliliter (mL).', 'interventionNames': ['Drug: SonoVue®']}], 'interventions': [{'name': 'Sonazoid™', 'type': 'DRUG', 'description': 'Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection.', 'armGroupLabels': ['Sonazoid™']}, {'name': 'SonoVue®', 'type': 'DRUG', 'description': 'Single Dose of SonoVue® 2.4 mL as I.V. injection.', 'armGroupLabels': ['SonoVue®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Dongcheng', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital, East Campus: No.1 Shuaifuyuan Wangfujing'}, {'zip': '100853', 'city': 'Haidan', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA General Hospital, No. 28 Fuxing Road'}, {'zip': '100032', 'city': 'Xicheng', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital, West Campus: No. 41 Damucang Hutong'}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun-Yat sen University, No. 58 Zhongshan Second Road', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhongshan University, No. 107 Yanjiang West Road', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '200080', 'city': 'Hongkou', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai First Hospital, North Campus: No. 100 Haining Road', 'geoPoint': {'lat': 31.25, 'lon': 121.48917}}, {'zip': '201620', 'city': 'Songjiang', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai First Hospital, South Campus: No.650 New Songjiang Road', 'geoPoint': {'lat': 31.03443, 'lon': 121.22326}}, {'zip': '200032', 'city': 'Xuhui', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University, No. 180 Fenglin Road', 'geoPoint': {'lat': 31.19594, 'lon': 121.44709}}, {'zip': '200040', 'city': 'Xuhui', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Hua Shan Hospital, No. 12 Wulumuqi Middle Road', 'geoPoint': {'lat': 31.19594, 'lon': 121.44709}}, {'zip': '200233', 'city': 'Xuhui', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Sixth Hospital, No. 600 Yishan Road', 'geoPoint': {'lat': 31.19594, 'lon': 121.44709}}, {'zip': '200072', 'city': 'Zhabei', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Tenth People's Hospital, No. 301 Yanchang Middle Road", 'geoPoint': {'lat': 31.25861, 'lon': 121.45972}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital, 101, Daehak-Ro, Jongno-Gu', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St Mary's Hospital, 222 Banpo-daero, Seocho-gu", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Douliu', 'state': 'Yunlin County', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital - Yunlin Branch, No. 579, Sec. 2 Yunlin Road', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital, No. 7 Chung-Shan South Road', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10449', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Mackay Memorial Hospital, No. 92, Sec. 2 Zhongshan N. Road', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10650', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Cathay General Hospital, No. 280 Jen-Ai Road, Sec. 4', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital, No. 201 Shih-Pai Road, Sec. 2', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Francois Tranquart, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'GE Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}