An Optimised Radiolabel Procedure to Prepare 99mTc-Colloidal Rhenium Sulphide to Improve Radiochemical Purity

Benoit      Hosten; Romain      Roche; Emmanuelle      Barre; Julien      Fouque; Yvan      Mouraeff; Agnes      Dumont; Catherine      LE Meur; Helene      Garrigue; Sabrina      Hassoun; Valerie      Nataf; Corinne      Smadja; Virginie      de Beco; Karine      Felice; Nathalie      Rizzo-Padoin

Abstract

Background: More than 25% of 99mTc colloidal rhenium sulphide preparations have been reported to have a radiochemical purity of < 95% in 11 radiopharmacies.

Objectives: To identify the key parameters involved in radiochemical purity, different preparation procedures were analysed to develop an optimised preparation method.

Methods: In the first part of this study, various data such as the Nanocis kit batch number, the eluate volume, the time between the two final elutions, the temperature and duration of heating were collected and analysed to determine the critical parameters that significantly decrease radiochemical purity. In the second part, a new procedure was applied and then the same parameters and radiochemical purity values were collected and compared with the results before the new procedure.

Results: Among 184 preparations, 137 (75%) had a radiochemical purity exceeding 95%, 25 (13.6%) were between 90 and 95% pure and 22 (12%) were below 90%. Significantly higher radiochemical purity was observed after the implementation of the new preparation procedure (89.5% of 374 preparations had radiochemical purities of > 95%). This new procedure consists in lowering the 99mTc eluate volume and time of heating.

Conclusions: The implementation of a new method for the preparation of 99mTc colloidal rhenium sulphide based on a comparison of practices in various radiopharmacies resulted in: i) a determination of the critical points of this preparation, ii) an optimised labelling technique to harmonise different practices, and iii) a significant improvement in the preparations radiochemical purity and the quality of the lymphoscintigraphy in the location of sentinel node.

Keywords: 99mTc colloidal rhenium, radiochemical purity, radiolabelling, quality control, radiopharmaceutical, radiochemical purities, colloidal rhenium sulphide, radiopharmacies