Alternatives for Accessing Lifesaving Diagnostic Radioisotopes: Cyclotron Based Gallium 68 for Cancer Detection

The IAEA has recognized there is a critical need for reliable access to Gallium-68 (Ga-68) radiopharmaceuticals, essential for both diagnostic and therapeutic purposes in nuclear medicine. Ga-68 PSMA (Prostate-Specific Membrane Antigen) is widely used to detect prostate cancer, identifying numerous cases daily worldwide and enabling effective treatment using Lutetium-177 (Lu-177).

Traditionally, Ga-68 has been produced using a Germanium 68 (Ge-68)/Ga-68 generator. However, due to the increasing costs and limited availability of these generators, the IAEA has promoted alternative production methods. One such method involves using medical cyclotrons, which are widely available. The IAEA's cyclotron database has compiled a list of all existing cyclotrons worldwide, enabling access to this technology. These cyclotrons can produce approximately 1 Curie (Ci) of Ga-68 per run using a solid target, whereas a generator usually provides a maximum of 40-50 millicuries (mCi) per run.

In 2019, the IAEA published a technical document outlining a straightforward and efficient method for Ga-68 production using cyclotrons. This document has become one of the most downloaded IAEA publications, underscoring its significance in ensuring the availability of Ga-68 for cancer detection and treatment.

The following year, the IAEA initiated a five year Coordinated Research Project (CRP) titled Production and Quality Control of Cyclotron-Based Ga-68 Radiopharmaceuticals, in response to requests from countries and to address challenges related to the regulatory aspects of the new production method. This project, expected to conclude in late 2024, aims to address various challenges faced in radiopharmaceutical production and optimize the process. An IAEA technical document summarizing the CRP outcomes will soon be published, covering topics such as solid and liquid target Ga-68 cyclotron production, radiopharmacy, preclinical and clinical advances and regulatory aspects.

To reflect the IAEA's efforts and recent advancements in the field, the IAEA hosted a global webinar on May 29, 2024. This webinar featured eight esteemed panellists from academia and industry, who presented highlights from the CRP. The 120-minute event attracted approximately 307 attendees from 71 countries, sparking enthusiastic interaction and valuable input from participants.

"It was an honour and a privilege to be learning from the best in the field. The Agency is really doing a fantastic job in Radiochemistry and Radiation Technology for the field and most importantly to young students like myself," said Alphonse Birorimana, Master of Science student at Fujita Health University, Japan.