Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sonazoid · 3 trials · 9 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. |
| 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 ultrasound contrast agent developed by GE HealthCare Technologies Inc. (ticker GEHC). It is used in contrast-enhanced ultrasound imaging, including detection of focal liver lesions and sentinel node detection in melanoma, breast cancer, and head and neck cancer. It is also being studied for noninvasive intracardiac pressure measurement during cardiac catheterization.
Sonazoid is used as a contrast agent for pre- and post-contrast ultrasound imaging in participants with focal liver lesions. A completed Phase 3 study, NCT03335566, evaluated its efficacy and safety compared with SonoVue in 424 participants across China, South Korea, and Taiwan.
Sonazoid is developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company sponsors the clinical development program for the agent across its imaging and diagnostic indications.
Sonazoid is in clinical development, with studies spanning Phase 2 and Phase 3. A Phase 3 trial in focal liver lesions has been completed, while a Phase 2 trial in sentinel node detection for melanoma and other cancers is currently recruiting. It remains an investigational agent.
Sonazoid has been studied in NCT03335566, a completed Phase 3 trial in focal liver lesions with 424 participants, and NCT03245255, a completed Phase 2 trial of noninvasive intracardiac pressure measurement with 80 participants. NCT07310758, a Phase 2 sentinel node detection study in melanoma, breast, and head and neck cancer, is recruiting in the Netherlands.
Yes, Sonazoid and Sonazoid™ refer to the same ultrasound contrast agent developed by GE HealthCare Technologies Inc. (GEHC). The trademark symbol is simply a stylized form of the same product name used in trial listings and labeling.