Table 2.
111In-CHX-A”-DTPA trastuzumab | |||||
---|---|---|---|---|---|
Radiochemical Purity (%) | Administered Dose Parameters | ||||
Patient ID | ITLC (Instant Thin Layer Chromatography) | Paper Chromatography | Activity (MBq) | mass (μg) | Specific Activity (MBq/μg) |
001 | 98.8 | 98.05 | 186.85 | 69.75 | 2.68 |
002 | 99.4 | 99.70 | 142.82 | 159.96 | 0.89 |
003 | 99.9 | 99.09 | 185 | 70.13 | 2.64 |
004 | 99.1 | 99.36 | 161.69 | 161.41 | 1.00 |
006 | 99.9 | 98.09 | 188.7 | 126.48 | 1.49 |
007 | 100 | 100.00 | 189.81 | 136.50 | 1.39 |
008# | 100 | 98.50 | 179.08 | 144.20 | 1.24 |
009 | 99.4 | 99.16 | 186.48 | 168.58 | 1.11 |
010 | 100 | 99.50 | 184.63 | 88.65 | 2.08 |
011 | 99.4 | 98.13 | 128.39 | 160.38 | 0.80 |
012 | 100 | 100.00 | 173.53 | 157.68 | 1.10 |
013 | 97.9 | 98.70 | 193.88 | 104.54 | 1.85 |
Average[SD] | 99.48 [0.64] | 99.02 [0.72] | 175.1 [20.5] MBq | 129.0 [36.8] | 1.52 [0.6] |
Twelve patients received 1 111In-CHX-A”-DTPA trastuzumab infusions; however, one patient (008) died of her disease prior to imaging. All clinical doses produced met Quality Control Acceptance criteria including radiochemical purity >95% and chemical mass <200μg