Phase 3
N=353
SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization
Liver Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00829413 ↗Enrolled (actual)
353
Serious AEs
1.2%
Results posted
Aug 2018
Primary outcome: Primary: Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard — 48.7; 86.6; 35.3; 75.6 Percentage of true positive lesions — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SonoVue® (Drug)
- 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 |
48.7; 86.6; 35.3; 75.6; 16.0; 91.6 | <.0001 sig |
| PRIMARY Specificity: Percentage of True Negative Lesions Among All Benign Lesions Per Truth Standard' |
62.9; 70.7; 54.3; 82.9; 22.1; 72.9 | 0.1380 |
| SECONDARY Accuracy: Percentage of True Positive and True Negative Among All Lesions |
56.4; 78.0; 45.6; 79.5; 19.3; 81.5 | <.0001 sig |
| SECONDARY Positive Predictive Value [PPV]: Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound |
52.7; 71.5; 39.6; 78.9; 14.8; 74.1 | <.0001 sig |
| SECONDARY Negative Predictive Value [NPV]: Percentage of True Negative Lesions Among All Benign Lesions Per Ultrasound |
59.1; 86.1; 49.7; 80.0; 23.7; 91.1 | <.0001 sig |
| SECONDARY Specific Diagnosis of Malignant FLLs |
47; 47; 47; 47; 47; 47 | — |
| SECONDARY Specific Diagnosis of Benign FLLs |
52; 52; 52; 52; 52; 52 | — |
| SECONDARY Inter-reader Agreement |
28.2; 66.0; 94.6; 99.6 | — |
Summary
The purpose of this study is to demonstrate the Sensitivity and Specificity of SonoVue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant FLLs using final diagnosis based on histology or combined imaging (CE-CT and/or CE MRI)/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 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 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 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 (NCT00829413). 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.