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High capacity H2ATSM kits for on-site synthesis of hypoxia-specific agent 64Cu-ATSM

¹ Proportional Technologies, Inc, Houston, Texas

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Objectives: 1) Demonstrate preparation of H2ATSM kits containing 4 µg of ligand. 2) Evaluate kit performance for 64Cu binding. 3) Report preliminary results toward expansion of kit capacity to 15 µg H2ATSM.

Methods: A 0.4 ppm aqueous solution of H2ATSM was prepared in 20 mg/mL excipient, standardized, and then sterile filtered. The solution was then shipped to a vendor for lyophilization. Ten mL aliquots were lyophilized into individual 50 mL serum vials to provide the ligand in a 200 mg excipient matrix. 64Cu radiochemical labeling was performed after kit reconstitution with 25 mM sodium acetate solution. Preliminary work toward further improvement of the H2ATSM kit binding capacity through enhancement of the ligand solubility will be presented.

Results: H2ATSM kits containing 4 µg of ligand were successfully prepared by Proportional Technologies through methods similar to those previously utilized to prepare 0.4 µg H2ATSM ligand kits. These kits have been successfully utilized to bind up to 30 mCi of 64Cu in radiochemical yields >93%, even in low specific activity samples where the kit binding capacity is nearly exhausted. To provide a margin of error for low specific activity 64Cu samples, H2ATSM kits having up to 15 µg ligand content are being developed.

Conclusions: H2ATSM kits having expanded binding capacity for formation of 64Cu-ATSM have been developed. These give high radiochemical labeling yields, even when the kit capacity is nearly exhausted by low specific activity material. Preliminary work has indicated that the kit ligand content can be expanded up to at least 15 µg through enhancement of the H2ATSM solubility. Development of the 15 µg kits opens the possibility of on-site synthesis of this hypoxia-specific PET imaging agent in multi-site clinical trials.

This Article Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Google Scholar Articles by Thrash, T. Articles by Lacy, J. PubMed Articles by Thrash, T. Articles by Lacy, J.