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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
424
Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection.
Single Dose of SonoVue® 2.4 mL as I.V. injection.
Peking Union Medical College Hospital, East Campus: No.1 Shuaifuyuan Wangfujing
Dongcheng, Beijing Municipality, China
Chinese PLA General Hospital, No. 28 Fuxing Road
Haidan, Beijing Municipality, China
Peking Union Medical College Hospital, West Campus: No. 41 Damucang Hutong
Xicheng, Beijing Municipality, China
The First Affiliated Hospital, Sun-Yat sen University, No. 58 Zhongshan Second Road
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Zhongshan University, No. 107 Yanjiang West Road
Guangzhou, Guangdong, China
Shanghai First Hospital, North Campus: No. 100 Haining Road
Hongkou, Shanghai Municipality, China
Shanghai First Hospital, South Campus: No.650 New Songjiang Road
Songjiang, Shanghai Municipality, China
Zhongshan Hospital Fudan University, No. 180 Fenglin Road
Xuhui, Shanghai Municipality, China
Shanghai Hua Shan Hospital, No. 12 Wulumuqi Middle Road
Xuhui, Shanghai Municipality, China
Shanghai Sixth Hospital, No. 600 Yishan Road
Xuhui, Shanghai Municipality, China
...and 8 more locations
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.
Time frame: Pre-administration up to 15 minutes post-administration
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.
Time frame: 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).
Time frame: 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.
Time frame: Pre-administration up to 15 minutes post-administration
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