Influential Factors in the Preparation of 68Ga-DOTATATE.

ABSTRACT

Acceptable and reproducible radiochemical purity (RP) for 68Ga-DOTATATE was difficult to obtain with the NETSPOT kit because the manufacturer instructions lacked details on the heater or needles used. Methods: The drug was prepared in an International Organization for Standardization (ISO) 5 environment. Multiple dry baths and needle types were used to investigate the effects of reaction temperature and metal contamination, respectively. Temperature curves were obtained with a calibrated thermocouple. The influence of the accuracy of the NETSPOT reagent volume and its effect on outcome were investigated. Results: The AccuBlock dry bath required recalibration for the ISO 5 environment; after calibration, the temperature was stable (only ±0.1°C from the set point). When we followed package insert recommendations (dry bath temperature set to 98°C, reaction time of 8 min), the reaction temperature was 90.6°C. When Becton Dickinson needles were used for reconstitution, 15 of 18 runs (83%) did not meet the RP specification. However, B. Braun Medical needles achieved satisfactory and stable RP. When the 68Ga generator was eluted with 5.0 mL of 0.1 M hydrochloric acid (HCl), only 3.8-3.9 mL of eluate reached the reaction vial; this volume did not impact labeling (final pH was 3.8). The labeling success rate increased markedly if the 68Ga eluate was passed through a conditioned silica gel cartridge or if no cartridge was used; then, RP was more than 99%. HCl contact with the septum of the labeling vial reduced RP. Conclusion: The needle type and the temperature setting of the dry bath have critical roles in 68Ga-DOTATATE preparation. The AccuBlock dry bath has excellent stability and accuracy and can be used for reliable preparation. By using a conditioned silica gel cartridge or by eliminating the cartridge altogether, the RP is reliably high and stable.