Improved purification of cyclotron [Ga]GaCl for the production of Ga radiopharmaceuticals.

Introduction: Increased demand for NetSpot and Illuccix as requirement to receive the respective Lutathera and Pluvicto radiotherapies, and monitor subsequent response to treatment, have reinforced the need to develop alternative ways of producing gallium-68 (Ga). Building on our efforts to produce Ga in a liquid target on a GE PETtrace, the goal of this work is to modify the current GE Gallium Chloride cassette using the FASTLab 2 synthesis module to produce [Ga]GaCl equivalent to a 1.85 GBq generator and demonstrate compatibility with FDA-approved kits for production of Ga-labeled radiopharmaceuticals.

Synthesis of Ga-radiopharmaceuticals using both generator-derived and cyclotron-produced Ga as exemplified by [Ga]Ga-PSMA-11 for prostate cancer PET imaging.

[Ga]Ga-PSMA-11, a urea-based peptidomimetic, is a diagnostic radiopharmaceutical for positron emission tomography (PET) imaging that targets the prostate-specific membrane antigen (PSMA). The recent Food and Drug Administration approval of [Ga]Ga-PSMA-11 for PET imaging of patients with prostate cancer, expected follow-up approval of companion radiotherapeutics (e.g.

Cyclotron-based production of Ga, [Ga]GaCl, and [Ga]Ga-PSMA-11 from a liquid target.

Purpose: To optimize the direct production of Ga on a cyclotron, via the Zn(p,n)Ga reaction using a liquid cyclotron target. We Investigated the yield of cyclotron-produced Ga, extraction of [Ga]GaCl and subsequent [Ga]Ga-PSMA-11 labeling using an automated synthesis module.

Methods: Irradiations of a 1.

Use of 55 PET radiotracers under approval of a Radioactive Drug Research Committee (RDRC).

Background: In the US, EU and elsewhere, basic clinical research studies with positron emission tomography (PET) radiotracers that are generally recognized as safe and effective (GRASE) can often be conducted under institutional approval. For example, in the United States, such research is conducted under the oversight of a Radioactive Drug Research Committee (RDRC) as long as certain requirements are met. Firstly, the research must be for basic science and cannot be intended for immediate therapeutic or diagnostic purposes, or to determine the safety and effectiveness of the PET radiotracer.