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
|Condition or disease||Intervention/treatment||Phase|
|Liver Lesions||Drug: Sonazoid™ Drug: SonoVue®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||424 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 11, 2014|
|Actual Primary Completion Date :||April 9, 2015|
|Actual Study Completion Date :||April 9, 2015|
Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight.
Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection.
Active Comparator: SonoVue®
Participants will receive single I.V bolus injection of SonoVue® 2.4 milliliter (mL).
Single Dose of SonoVue® 2.4 mL as I.V. injection.
- 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 ]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.
- 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) [ Time Frame: Pre-administration up to 15 minutes post-administration ]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.
- Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results [ Time Frame: Pre-administration up to 15 minutes post-administration ]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).
- 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 [ Time Frame: Pre-administration up to 15 minutes post-administration ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335566
|Peking Union Medical College Hospital, East Campus: No.1 Shuaifuyuan Wangfujing|
|Dongcheng, Beijing, China, 100730|
|Chinese PLA General Hospital, No. 28 Fuxing Road|
|Haidan, Beijing, China, 100853|
|Peking Union Medical College Hospital, West Campus: No. 41 Damucang Hutong|
|Xicheng, Beijing, China, 100032|
|The First Affiliated Hospital, Sun-Yat sen University, No. 58 Zhongshan Second Road|
|Guangzhou, Guangdong, China, 510080|
|The Second Affiliated Hospital of Zhongshan University, No. 107 Yanjiang West Road|
|Guangzhou, Guangdong, China, 510120|
|Shanghai First Hospital, North Campus: No. 100 Haining Road|
|Hongkou, Shanghai, China, 200080|
|Shanghai First Hospital, South Campus: No.650 New Songjiang Road|
|Songjiang, Shanghai, China, 201620|
|Zhongshan Hospital Fudan University, No. 180 Fenglin Road|
|Xuhui, Shanghai, China, 200032|
|Shanghai Hua Shan Hospital, No. 12 Wulumuqi Middle Road|
|Xuhui, Shanghai, China, 200040|
|Shanghai Sixth Hospital, No. 600 Yishan Road|
|Xuhui, Shanghai, China, 200233|
|Shanghai Tenth People's Hospital, No. 301 Yanchang Middle Road|
|Zhabei, Shanghai, China, 200072|
|Korea, Republic of|
|Seoul National University Hospital, 101, Daehak-Ro, Jongno-Gu|
|Seoul, Korea, Republic of, 110-744|
|Seoul St Mary's Hospital, 222 Banpo-daero, Seocho-gu|
|Seoul, Korea, Republic of, 137-701|
|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, Taiwan, 100|
|Mackay Memorial Hospital, No. 92, Sec. 2 Zhongshan N. Road|
|Taipei, Taiwan, 10449|
|Cathay General Hospital, No. 280 Jen-Ai Road, Sec. 4|
|Taipei, Taiwan, 10650|
|Taipei Veterans General Hospital, No. 201 Shih-Pai Road, Sec. 2|
|Taipei, Taiwan, 112|
|Study Chair:||Francois Tranquart, MD, PhD||GE Healthcare|