Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sonazoid · 4 trials · 10 indications
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.
To assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Could CEUS replace the conventional radioactive technetium method?
The Pearson correlation coefficient was computed between the simultaneously acquired subharmonic signal and pressure catheter data (i.e., waveforms) for each participant. The Pearson correlation coefficient was used for comparing waveforms given the underlying data and pressure values used for comparisons followed a normal distribution. Values reported will be the mean Pearson correlation coefficient values between the subharmonic waveforms and pressure catheter waveforms obtained.
Based on the distribution of the differences in cardiac pressure values obtained using the SHAPE technique and the clinical pressure catheter, either a two-tailed paired t test (normal distribution) or Wilcoxon signed rank test (nonnormal distribution) was used to compare the SHAPE technique to the reference standard. Bonferroni corrections were used for multiple comparisons
| 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). |
| Intra-operative Sonazoid injection | OTHER | - |
| Sonazoid for pressure measurements | EXPERIMENTAL | 48 µl of Sonazoid microbubbles (GE Healthcare, Oslo, Norway) will be co-infused at a rate of 0.024 µl/kg body weight/minute together with a 0.9% sodium chloride solution infused at a rate of at least 2 ml/min. |
| Sonazoid™ 0.12 microliter (µl) | EXPERIMENTAL | Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 µl microbubbles (MB)/kilogram (kg) body weight. |
| Sonazoid™ 0.60 µl | EXPERIMENTAL | Participants will receive single I.V bolus injection of Sonazoid™ 0.60 µl MB/kg body weight. |
| 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. |
| Sonazoid | DRUG | Intradermal injection of the ultrasound contrast agent Sonazoid. |
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 ...
Sonazoid is an investigational ultrasound contrast agent being studied for use in cardiac catheterization, liver lesion imaging, and sentinel node detection in melanoma, breast cancer, and head and neck cancer. It is also being evaluated in healthy volunteers for pharmacokinetic studies. Sonazoid is developed by GE HealthCare Technologies Inc. (GEHC).
Sonazoid is a small molecule ultrasound contrast agent. It works by enhancing ultrasound imaging through the reflection of sound waves, improving the visualization of blood flow and tissue structures. This mechanism aids in the detection and characterization of lesions and in measuring intracardiac pressures during procedures.
Sonazoid is developed by GE HealthCare Technologies Inc., traded on the New York Stock Exchange under the ticker GEHC. The company is conducting clinical trials to evaluate the safety and efficacy of Sonazoid for various imaging applications, including liver lesion assessment and cardiac procedures.
Sonazoid is in Phase 2 clinical development. It has completed Phase 1 and Phase 3 trials, and a Phase 2 trial is currently recruiting participants. Sonazoid is investigational and has not been approved by the FDA for any indication.
Sonazoid is being studied in several clinical trials. NCT03245255 is a completed Phase 2 trial for cardiac catheterization. NCT03335566 is a completed Phase 3 trial for liver lesions. NCT03340870 is a completed Phase 1 trial in healthy volunteers. NCT07310758 is a recruiting Phase 2 trial for sentinel node detection in melanoma, breast cancer, and head and neck cancer.
No, Sonazoid and SonoVue are different ultrasound contrast agents. They were compared in a Phase 3 clinical trial (NCT03335566) for imaging focal liver lesions. The study evaluated the efficacy and safety of both agents in participants undergoing pre- and post-contrast ultrasound imaging.