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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02652923 | Contrast Ultrasound Detection of Sentinel Lymph Nodes | PHASE1 | COMPLETED | 98 | — | — | Jan 1, 2016 | Jan 12, 2022 | Jan 23, 2023 | 1 | United States |
To establish, in healthy, female volunteers, the optimal dose of subdermaly administrated Sonazoid (an ultrasound contrast agent) employed for contrast enhanced ultrasound imaging (CEUS)
To assess the safety and tolerability of subdermal administration of Sonazoid in 12 female, healthy volunteers.
To determine if CEUS of subdermally administrated Sonazoid (i.e., lymphosonography) identify more sentinel lymph nodes (SLNs) in patients with breast cancer compared to isotope mapping (with Tc-99m sulfur colloids) using blue dye and surgical dissection as the reference standard. The fundamental hypothesis is that on average lymphosonography will detect 3.2 SLNs compared to 2.7 with isotope mapping.
| Arm | Type | Description |
|---|---|---|
| Part 1 - volunteers | EXPERIMENTAL | Subdermal low (1.0 ml) or high (2.0 ml) dose injection of the ultrasound contrast agent Sonazoid divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock) around a 2 cm in diameter region in the mid-upper outer quadrant of the left breast, followed a week later by the other dose injected in the same fashion into the right breast. |
| Part 2 - patients | EXPERIMENTAL | Subdermal injection of the ultrasound contrast agent of Sonazoid divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock) around the breast cancer. Subjects will receive an injection of either a low (1.0 ml) or a high (2.0 ml) dose of Sonazoid depending on the outcome of the Part 1 safety and tolerability study. |
| Name | Type | Description |
|---|---|---|
| Sonazoid; Perflubutane for Injection | DRUG | subdermal injection into the breast of Sonazoid (1 or 2 ml) divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock) |
Inclusion Criteria: * Part 1: * Be female. * Be at least 21 years of age. * Must have a body mass index (BMI) greater or equal to 19 and less than or equal to 33. * Be able to comprehend the full nature, purpose and risks of the study. * Part 2: * Be female. * Be diagnosed with breast...