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| ID | Type | Description | Link |
|---|---|---|---|
| GE-045-002 | Other Identifier | GE HealthCare |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonazoid™ | Experimental | Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight. |
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| SonoVue® | Active Comparator | Participants will receive single I.V bolus injection of SonoVue® 2.4 milliliter (mL). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonazoid™ | Drug | Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-administration up to 15 minutes post-administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria: Participants may be included in the study if they meet all of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francois Tranquart, MD, PhD | GE Healthcare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, East Campus: No.1 Shuaifuyuan Wangfujing | Dongcheng | Beijing Municipality | 100730 | China | ||
Participants were randomised in 1:1 ratio to receive either Sonazoid™ or SonoVue®.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sonazoid™ | Participants received single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight. |
| FG001 | SonoVue® | Participants received single I.V bolus injection of SonoVue® 2.4 milliliter (mL). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| SonoVue® |
| Drug |
Single Dose of SonoVue® 2.4 mL as I.V. injection. |
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| Pre-administration up to 15 minutes post-administration |
| 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). | Pre-administration up to 15 minutes post-administration |
| 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. | Pre-administration up to 15 minutes post-administration |
| Chinese PLA General Hospital, No. 28 Fuxing Road |
| Haidan |
| Beijing Municipality |
| 100853 |
| China |
| Peking Union Medical College Hospital, West Campus: No. 41 Damucang Hutong | Xicheng | Beijing Municipality | 100032 | China |
| The First Affiliated Hospital, Sun-Yat sen University, No. 58 Zhongshan Second Road | Guangzhou | Guangdong | 510080 | China |
| The Second Affiliated Hospital of Zhongshan University, No. 107 Yanjiang West Road | Guangzhou | Guangdong | 510120 | China |
| Shanghai First Hospital, North Campus: No. 100 Haining Road | Hongkou | Shanghai Municipality | 200080 | China |
| Shanghai First Hospital, South Campus: No.650 New Songjiang Road | Songjiang | Shanghai Municipality | 201620 | China |
| Zhongshan Hospital Fudan University, No. 180 Fenglin Road | Xuhui | Shanghai Municipality | 200032 | China |
| Shanghai Hua Shan Hospital, No. 12 Wulumuqi Middle Road | Xuhui | Shanghai Municipality | 200040 | China |
| Shanghai Sixth Hospital, No. 600 Yishan Road | Xuhui | Shanghai Municipality | 200233 | China |
| Shanghai Tenth People's Hospital, No. 301 Yanchang Middle Road | Zhabei | Shanghai Municipality | 200072 | China |
| Seoul National University Hospital, 101, Daehak-Ro, Jongno-Gu | Seoul | 110-744 | South Korea |
| Seoul St Mary's Hospital, 222 Banpo-daero, Seocho-gu | Seoul | 137-701 | South Korea |
| National Taiwan University Hospital - Yunlin Branch, No. 579, Sec. 2 Yunlin Road | Douliu | Yunlin County | Taiwan |
| National Taiwan University Hospital, No. 7 Chung-Shan South Road | Taipei | 100 | Taiwan |
| Mackay Memorial Hospital, No. 92, Sec. 2 Zhongshan N. Road | Taipei | 10449 | Taiwan |
| Cathay General Hospital, No. 280 Jen-Ai Road, Sec. 4 | Taipei | 10650 | Taiwan |
| Taipei Veterans General Hospital, No. 201 Shih-Pai Road, Sec. 2 | Taipei | 112 | Taiwan |
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| NOT COMPLETED |
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Analysis was performed on safety analysis set that included all enrolled participants who received either Sonazoidâ„¢ or SonoVue.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sonazoid™ | Participants received single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight. |
| BG001 | SonoVue® | Participants received single I.V bolus injection of SonoVue® 2.4 milliliter (mL). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category. | Posted | Number | percentage of participants | Pre-administration up to 15 minutes post-administration |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category. | Posted | Median | Inter-Quartile Range | Lesions | Pre-administration up to 15 minutes post-administration |
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| Secondary | 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). | Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category. | Posted | Count of Participants | Participants | Pre-administration up to 15 minutes post-administration |
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| Secondary | 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. | Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category. | Posted | Number | percentage of participants | Pre-administration up to 15 minutes post-administration |
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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.
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®.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sonazoid™ | Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight. | 0 | 218 | 0 | 218 | 0 | 218 |
| EG001 | SonoVue® | Participants received single I.V bolus injection of SonoVue® 2.4 mL. | 0 | 206 | 0 | 206 | 0 | 206 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francois Tranquart, M.D, PhD | GE Healthcare | 011-44-1494-543037 | francois.tranquart@ge.com |
| ID | Term |
|---|---|
| C069727 | Sonazoid |
| C420843 | contrast agent BR1 |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Reader 2 |
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| Reader 3 |
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| Participants |
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| Probable (2 points) |
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| Not confident (1 point) |
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| Unknown (0 points) |
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| Probable (2 points) |
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| Not confident (1 point) |
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| Unknown (0 points) |
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| Probable (2 points) |
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| Not confident (1 point) |
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| Unknown (0 points) |
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| Probable (2 points) |
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| Not confident (1 point) |
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| Unknown (0 points) |
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| Probable (2 points) |
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| Not confident (1 point) |
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| Unknown (0 points) |
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