Characterization of Focal Liver Lesions With SONOVUE®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Un-enhanced Ultrasound Imaging Using Histology or Combined Imaging/Clinical Data as Truth Standard
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 1
- 主要终点
- Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard
研究概览
简要总结
The purpose of this study is to demonstrate the superiority of SonoVue®-enhanced ultrasound versus unenhanced ultrasound for characterization of Focal Liver Lesions using final diagnosis based on histology or combined imaging/clinical data as truth standard.
详细描述
Unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female.
- •Provides written Informed Consent and is willing to comply with protocol requirements.
- •Is at least 18 years of age.
- •Has at least 1 focal liver lesion (FLL) (target lesion) requiring work-up for characterization. Target lesions may include those:
- •Incidentally detected,
- •In subjects with chronic hepatitis or liver cirrhosis,
- •In subjects with known history of malignancy.
- •Is scheduled for surgical removal or biopsy of the target lesion from 24 hours to 30 days after the SonoVue® administration OR
- •In case tissue biopsy is not indicated nor surgery planned, is scheduled for or has performed a contrast-enhanced (CE) CT and/or CE-MRI of the target lesion from 30 days to 48 hours prior to or from 24 hours to 30 days after the administration of SonoVue®.
排除标准
- •Has an acoustic window insufficient for adequate ultrasound examination of the liver.
- •Has a FLL that cannot be identified with unenhanced ultrasound.
- •Has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion.
- •Is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of SonoVue®.
- •Has previously been enrolled in and completed this study.
- •Known right to left cardiac shunt, bidirectional or transient.
- •Has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of SonoVue®).
- •Has any contraindication to 1 of the planned imaging procedures (ultrasound, CT or MRI), e.g., implants, claustrophobia, inadequate medical conditions etc.
- •Has received an investigational compound within 30 days before admission into this study.
- •Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
- •Is determined by the Investigator that the subject is clinically unsuitable for the study.
- •Is a pregnant or lactating female. Exclude the possibility of pregnancy by:
- •testing on site at the institution serum beta-human chorionic gonadotropin (βHCG) within 24 hours prior to the start of SonoVue® administration,
- •surgical history (e.g., tubal ligation or hysterectomy),
- •post menopausal with a minimum 1 year without menses.
研究组 & 干预措施
Patients who received SonoVue
Patients with at least 1 target lesion requiring work-up for characterization to undergo
- Unenhanced ultrasound of the target lesion (UE-US): gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion using commercially available ultrasound equipment and standard techniques (B-mode or Harmonic imaging) to study the anatomy of the target lesion and surrounding parenchyma;
- SonoVue-enhanced ultrasound of the target lesion (CE-US): procedures described in protocol Section 7.5.1.2, to study the lesion vascularity in comparison to the surrounding parenchyma; and
- Truth standard
干预措施: SonoVue-enhanced ultrasound (Drug)
Patients who received SonoVue
Patients with at least 1 target lesion requiring work-up for characterization to undergo
- Unenhanced ultrasound of the target lesion (UE-US): gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion using commercially available ultrasound equipment and standard techniques (B-mode or Harmonic imaging) to study the anatomy of the target lesion and surrounding parenchyma;
- SonoVue-enhanced ultrasound of the target lesion (CE-US): procedures described in protocol Section 7.5.1.2, to study the lesion vascularity in comparison to the surrounding parenchyma; and
- Truth standard
干预措施: Unenhanced ultrasound (Other)
结局指标
主要结局
Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard
时间窗: 24 hours to 6 months
Sensitivity of SonoVue-enhanced ultrasound (SonoVue CE-US) versus unenhanced ultrasound (UE-US) for characterization of malignant focal liver lesions (FLLs), using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the Intent-to-Diagnose (ITD) population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard. Truth standard: contrast-enhanced computed tomography (CE CT) and /or contrast-enhanced magnetic resonance imaging (CE-MRI) examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per truth standard) x 100.
Specificity: Percentage of True Negative Lesions Among All Malignant Lesions Per Truth Standard
时间窗: 24 hours to 6 months
Specificity of SonoVue-enhanced versus unenhanced ultrasound for characterization of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard. Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per truth standard) x 100.
次要结局
- Negative Predictive Value (NPV): Percentage of True Negative Lesions Among All Malignant Lesions Per Ultrasound(24 hours to 6 months)
- Positive Predictive Value (PPV): Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound(24 hours to 6 months)
- Inter-reader Agreement(24 hours to 6 months)
- Specific Diagnosis of Benign FLLs(24 hours to 6 months)
- Accuracy: Percentage of True Positive and True Negative Among All Lesions(24 hours to 6 months)
- Specific Diagnosis of Malignant FLLs(24 hours to 6 months)