Phase 3
N=349
SonoVue®-Enhanced Ultrasound Versus Unenhanced US for Focal Liver Lesion Characterization
Liver Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00788697 ↗Enrolled (actual)
349
Serious AEs
1.5%
Results posted
Jun 2017
Primary outcome: Primary: Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard — 53.2; 64.5; 41.1; 60.5 Percentage of true positive lesions — p=0.0754
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SonoVue-enhanced ultrasound (Drug); Unenhanced ultrasound (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bracco Diagnostics, Inc
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard |
53.2; 64.5; 41.1; 60.5; 66.1; 46.8 | 0.0754 |
| PRIMARY Specificity: Percentage of True Negative Lesions Among All Malignant Lesions Per Truth Standard |
24.1; 71.6; 6.9; 67.2; 58.6; 87.9 | <.0001 sig |
| SECONDARY Accuracy: Percentage of True Positive and True Negative Among All Lesions |
39.2; 67.9; 24.6; 63.8; 62.5; 66.7 | <.0001 sig |
| SECONDARY Positive Predictive Value (PPV): Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound |
42.9; 70.8; 32.1; 66.4; 63.1; 80.6 | <.0001 sig |
| SECONDARY Negative Predictive Value (NPV): Percentage of True Negative Lesions Among All Malignant Lesions Per Ultrasound |
32.6; 65.4; 9.9; 61.4; 61.8; 60.7 | <.0001 sig |
| SECONDARY Specific Diagnosis of Malignant FLLs |
84; 84; 84; 84; 84; 84 | — |
| SECONDARY Specific Diagnosis of Benign FLLs |
64; 64; 64; 64; 64; 64 | — |
| SECONDARY Inter-reader Agreement |
32.1; 51.7; 97.1; 91.7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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®.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00788697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.