Phase 3
N=424
An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging
Liver Lesions
Bottom Line
View on ClinicalTrials.gov: NCT03335566 ↗Enrolled (actual)
424
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: 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 — 18.1; 24.2; 22.1; 14.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sonazoid™ (Drug); SonoVue® (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
18.1; 24.2; 22.1; 14.6; 17.0; 16.7 | — |
| SECONDARY 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) |
0.0; 0.0; 0.0; -1.0; 0.0; -1.0 | — |
| SECONDARY Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results |
10; 11; 113; 122; 46; 36 | — |
| SECONDARY 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 |
11.9; 21.7; 16.6; 15.2; 15.8; 19.1 | — |
Summary
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).
Eligibility Criteria
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 = 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
Data sourced from ClinicalTrials.gov (NCT03335566). 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.