NCT03335566已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 18
- 主要终点
- 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
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants may be included in the study if they meet all of the following criteria:
- •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
- •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)
- •Participant is a 20- to 80-year-old inpatient or outpatient referred for an ultrasound examination of the liver
- •Participant is able and willing to comply with study procedures and will give their signed and dated informed consent
- •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
排除标准
- •The participant has an acute clinically fatal condition (i.e., not expected to survive for at least 6 months)
- •The participant has previously received Sonazoid™ or has received SonoVue® within the past 30 days
- •The participant has undergone or is undergoing systemic or loco-regional chemotherapy, or radiation therapy
- •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
- •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)
- •The participant has known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue®
- •The participant has undergone or plans to undergo liver biopsy or surgery within the 24 hours before or after this examination
- •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
- •The participant is considered to be unsuitable to participate in the study by the investigator
- •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
- •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
- •The participant has adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
- •The participant has known thrombosis within the liver, portal, or mesenteric veins
研究组 & 干预措施
Sonazoid™
Experimental
Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight.
干预措施: Sonazoid™ (Drug)
SonoVue®
Active Comparator
Participants will receive single I.V bolus injection of SonoVue® 2.4 milliliter (mL).
干预措施: SonoVue® (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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(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)(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(Pre-administration up to 15 minutes post-administration)
研究者
研究点 (18)
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