Preparation of [ 68 Ga]GaCl 3 Using a Cyclotron.

Recent developments in 68 Ga-radiopharmaceuticals, including a number of regulatory approvals for clinical use, has created a hitherto unprecedented demand for 68 Ga. Reliable access to enough 68 Ga to meet growing clinical demand using only 68 Ge/68 Ga generators has been problematic in recent years. To address this challenge, we have optimized the direct production of 68 Ga on a cyclotron via the 68 Zn(p,n)68 Ga reaction using a liquid target. This protocol describes the cyclotron-based production of [68 Ga]GaCl3 implemented at the University of Michigan using a liquid target on GE PETtrace instrumentation. The protocol provides 56 ± 4 mCi (n = 3) of [68 Ga]GaCl3 that meets the necessary quality control criteria to use for the preparation of 68 Ga-radiopharmaceuticals for human use.