Table 2. Summary of Phase 1/2a Data for All 24 Patients.
| Measures | Results |
|---|---|
| Adverse events, No. | 0 |
| Nerve injury, No. | 0 |
| Cases with improved surgical procedure, No.a | 4 |
| Optimal concentration | 5 nmol/mL |
| Dose | 2 nmol in 0.4 mL |
| Minimum dose | 0.5 nmol in 0.4 mL |
| Maximum dose | 4 nmol in 0.4 mL |
| Time from dose to first node visualization, range, min | 30-80 |
| Maximum signal-to-background ratio | 40 |
| Nodes excised for histology, No. | 40 |
| Pathology-positive nodes, No. | 6 |
| Fluorescent nodes that were also positive for pathology, No./total No.b | 5/6 |
a
Use of nanoparticles led to subjective assessments indicating altered surgical approach, reduced dissection, identifying small (ie, <4 mm) nodes, and discrimination of node from adjacent primary lesion.
b
There was a camera malfunction in 1 case.