IAEA Emphasizes Importance of Ga-68 Radiopharmaceuticals and Advances in Production Methods

In 2019, the IAEA published a technical document detailing a straightforward and efficient method for Ga-68 production using cyclotrons.

The International Atomic Energy Agency (IAEA) has underscored the critical need for reliable access to Gallium-68 (Ga-68) radiopharmaceuticals, which are crucial for both diagnostic and therapeutic purposes in nuclear medicine. Ga-68 PSMA (Prostate-Specific Membrane Antigen) is particularly significant for detecting prostate cancer, identifying numerous cases globally and enabling effective treatment using Lutetium-177 (Lu-177).

Traditionally, Ga-68 has been produced using Germanium-68 (Ge-68)/Ga-68 generators. However, rising costs and limited availability of these generators have prompted the IAEA to explore alternative production methods. One viable alternative involves using medical cyclotrons, which are more widely accessible. The IAEA's cyclotron database has compiled a comprehensive list of existing cyclotrons worldwide, facilitating access to this technology. Medical cyclotrons can produce approximately 1 Curie (Ci) of Ga-68 per run with a solid target, compared to the 40-50 millicuries (mCi) per run typically provided by a generator.

In 2019, the IAEA published a technical document detailing a straightforward and efficient method for Ga-68 production using cyclotrons. This publication has become one of the most downloaded IAEA documents, highlighting its importance in ensuring the availability of Ga-68 for cancer detection and treatment.

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

To reflect these efforts and advancements, the IAEA hosted a global webinar on May 29, 2024. The event featured eight esteemed panellists from academia and industry who presented highlights from the CRP. The 120-minute webinar attracted approximately 307 attendees from 71 countries, generating 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, a Master of Science student at Fujita Health University, Japan.

The IAEA continues to cultivate a global community of professionals capable of producing radioisotopes and ensuring the safety and quality of radiopharmaceuticals to combat non-communicable diseases. This webinar is part of a series dedicated to advancing this mission.

Upcoming Events and Future Prospects

A new webinar, "Status and Prospects of Alpha Emitters," is scheduled for February 12, 2025, at 14:00 CET. This session will address the growing interest in the production and application of emerging alpha emitter radiopharmaceuticals and discuss recommendations from a recent IAEA technical document on Actinium-225 radiopharmaceuticals, as well as future potential alpha emitter radiopharmaceuticals. Registration details can be found here.

Additionally, the IAEA Ministerial Conference on Nuclear Science, Technology, and Applications, along with the Technical Cooperation Programme, will take place from November 26-28, 2024. This conference will provide an opportunity for Member States and other partners to discuss topics of interest, with a focus on health, including a panel session on medical radioisotopes and radiopharmaceuticals for better health. The conference will also address issues related to climate change, food security and safety, and water resource management.