In cancer treatment, Targetted Alpha Therapy (TAT) has recently demonstrated encouraging clinical results that are stimulating significant attention from the research community, clinicians and professional societies. However, the main limitation for the wide application of TAT is the availability of suitable radionuclides, as well as approved guidelines and protocols for the production and quality control of these radiopharmaceuticals. Special training and education is also required for working with alpha emitters, as their use differs from working with traditionally used radionuclides. Due to the advances in the preparation and clinical application of alpha emitter radiopharmaceuticals, especially actinium-225 (Ac-225), a 2019 IAEA General Conference resolution has requested the Secretariat to assist Member States with capacity building for the development, production, and quality control of this new generation of therapeutic radiopharmaceuticals.
TAT is based on the target specific delivery of alpha emitting radionuclides using selective delivery vectors, such as peptides and antibodies. This is ideal from the perspective of the Targeted Radionuclide Therapy (TRT) concept, which facilitates maximizing damage to targeted cells and minimizing the toxicity effect on surrounding healthy tissues. Despite some promising clinical results there is still a significant research effort required to gain a better understanding of the formulation of stable radiopharmaceuticals, microdosimetry, and statistical validation based on significant numbers of clinical studies.
One of the major limitations of conducting extensive research on the most promising alpha emitters is their availability. Hence, this IAEA coordinated research project (CRP) will initiate formation of a global network among producers and researchers for the development of producing radiopharmaceutical based on Ac-225. The CRP is expected to develop standard procedures and guidelines for the production, quality control and preclinical studies of Ac-225 radiopharmaceuticals with the most potent clinically relevant radiopharmaceuticals on demand.
CRP Overall Objective:
CRP shall focus on production and quality control of Ac-225 radiopharmaceuticals (such as peptides, immunoconjugates, small molecules), addressing all aspects prior to clinical applications including quality control, pre-clinical studies and health regulatory issues.
Specific Research Objectives:
- Quality control and quality assurance of alpha emitter radioisotope (i.e. Ac-225) received from various sources
- Production of Ac-225 radiopharmaceuticals (including small molecules, peptides, antibodies, etc.)
- Quality control and stability of Ac-225 radiopharmaceuticals
- Non-clinical studies including in vitro cell studies and in vivo animal studies for evaluating stability, dosimetry, therapeutic efficacy and possible side effects
- Preparation and formulation of appropriate protocols and guidelines accessible for all IAEA Member States
Criteria:
- Participating centres shall have experience with theranostic radiometal radiopharmaceutical production and quality control
- Shall be equipped with labelled compound quality control equipment, such as thin layer chromatography (TLC), high performance liquid chromatography (HPLC) for radiochemical purity detection, a cross calibrated dose calibrator, a high resolution gamma detector with a multichannel analyser (MCA)
- Centres need to demonstrate radiological approval to work with Ac-225
How to join this CRP:
