Table 3.
Intraoperative mapping results
| Measurement | Pooled analysis |
|---|---|
| Patients injected with both vital blue dye and [99mTc]tilmanocept | N = 148 |
| Detection rate,a No. of patients (%) | |
| Blue (ITT patients) | 131 (88.5) |
| Radioactive | 146 (98.6) |
| p value, blue vs. radioactiveb | <0001 |
| Detection rate, No. of nodes (%) | 326 |
| Blue | 209 (64.1) |
| Radioactive | 320 (98.2) |
| p value, blue vs radioactiveb | <0001 |
| Average blue nodes per ITT patient, No. | 1.60 |
| ITT patients with ≥1 radioactive node, No. (%) | 131 (100.0) |
| Average radioactive nodes per patient, No. | 2.19 |
| Patients with ≥1 blue node, No. (%) | 131 (89.7) |
| Pathologically positive lymph nodes | 33 |
| Blue and radioactive, No. (%) | 25 (75.8) |
| Blue and not radioactive, No. (%) | 0 (0.0) |
| Radioactive and not blue, No. (%) | 6 (18.2) |
| Not blue and not radioactive, No. (%)c | 2 (6.1) |
| Pathologically positive node detection rate | |
| Vital blue dye, No. (%) | 25 (75.8) |
| [99mTc]tilmanocept, No. (%) | 31 (93.9) |
| p valueb | 0.0312 |
| Failed detection rate by node | |
| Vital blue dye (%) | 24.24 |
| [99mTc]tilmanocept (%) | 6.06 |
| p valueb | 0.0312 |
| Patients with missed positive nodesd | |
| No. of patients with at least 1 pathologically positive node | 27 |
| ≥1 node missed by vital blue dye, No. (%) | 6 (22.2) |
| ≥1 node missed by [99mTc]tilmanocept, No. (%)c | 1 (3.7) |
N number of patients injected with both [99mTc]tilmanocept and vital blue dye and who underwent surgery, blue blue-stained lymph node, radioactive radioactive lymph node (see Methods section)
aAt least 1 lymph node
b2-sided p value for exact McNemar’s test
cBoth nodes from the same patient, both nodes were palpably enlarged and tumor replaced
dFrom patients injected with both [99mTc]tilmanocept and vital blue dye and who underwent surgery