Building a compliant alpha-therapy program.
Centers preparing to deliver targeted alpha therapy need to evaluate their radioactive materials license, radiation protection program, and isotope-specific handling procedures.
Radioactive materials licensing
Centers must hold (or amend) an NRC or Agreement State radioactive materials license authorizing receipt, possession, and medical use of the relevant isotope. Authorized User (AU) designation under 10 CFR 35 — or the state equivalent — is typically required for the administering physician.
- →License amendment for new isotope categories
- →Authorized User training and experience requirements
- →Authorized Medical Physicist (AMP) involvement
- →Written directives and recordkeeping
Radiation Safety Officer (RSO)
The RSO is responsible for the radiation protection program. For alpha-emitter programs, the RSO should evaluate alpha-specific contamination controls, daughter isotope considerations, and decay-in-storage workflows that differ from existing beta/gamma therapeutics.
- →Program audit and ALARA review
- →Staff dosimetry and bioassay programs
- →Incident response procedures
Alpha-emitter–specific considerations
Ac-225 differs from Lu-177 in important ways: alpha particles are not detected by typical survey meters used for beta/gamma, contamination monitoring relies on wipe tests and alpha-sensitive instruments, and the decay chain produces additional alpha- and beta-emitting daughters that must be accounted for in shielding and waste planning.
- →Alpha-capable contamination monitoring
- →Decay-chain daughter management
- →Aerosolization and ingestion as primary exposure pathways
- →Waste decay storage informed by full chain half-lives
Regulatory guidance
This content is educational and not a substitute for guidance from the NRC, your Agreement State regulator, or your institution's Radiation Safety Committee. Requirements vary by jurisdiction and by the specific isotope and product authorized for use.