Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03335566 | An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging | PHASE3 | COMPLETED | 424 | — | — | May 11, 2014 | Apr 9, 2015 | Oct 31, 2018 | 18 | China, South Korea +1 |
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.
| Arm | Type | Description |
|---|---|---|
| Sonazoid™ | EXPERIMENTAL | Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight. |
| SonoVue® | ACTIVE_COMPARATOR | Participants will receive single I.V bolus injection of SonoVue® 2.4 milliliter (mL). |
| Name | Type | Description |
|---|---|---|
| Sonazoid™ | DRUG | Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection. |
| SonoVue® | DRUG | Single Dose of SonoVue® 2.4 mL as I.V. injection. |
Inclusion Criteria: 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 ...