How do you run a first-in-human radiopharmaceutical (theranostic) trial?

Radiopharmaceutical (theranostic) first-in-human trials require nuclear-medicine-capable sites, dosimetry, and supply-chain timing built around short isotope half-lives (Lu-177, Ac-225, Ga-68). bioaccess® runs them with U.S. regulatory anchoring (FDA Pre-Sub, IND) and Latin American execution — meaningfully faster and at lower cost.

From the Global Trial Accelerators™ podcast (hosted by bioaccess®), with Dr. Jason Hurt of Theragnostic Insights: watch the episode.

Why radiopharmaceutical trials need a specialized setup

Nuclear-medicine-capable sites with radiation licensing and hot-lab / radiopharmacy handling
Dosimetry and PET/SPECT imaging to characterize biodistribution and absorbed dose
Supply-chain timing built around isotope half-lives — Lu-177 (~6.6 days) ships; Ga-68 (~68 min) and Ac-225 need on-site or regional generation
U.S. regulatory anchoring (FDA Pre-Sub, IND) so the data supports the intended pathway
Latin American execution for materially faster timelines and lower per-patient cost

Frequently asked questions

What is a radiopharmaceutical (theranostic) clinical trial?

A radiopharmaceutical trial studies a drug that carries a radioactive isotope to diagnose or treat disease — often a theranostic pair that images and treats the same target. First-in-human radiopharmaceutical trials assess safety, biodistribution, dosimetry, and early efficacy, and require nuclear-medicine infrastructure most general sites lack.

What infrastructure does a radiopharmaceutical trial need?

Nuclear-medicine-capable sites with radiation licensing, hot-lab/radiopharmacy handling, dosimetry and imaging (PET/SPECT), and supply-chain logistics timed to short isotope half-lives. Lu-177 (~6.6-day half-life) allows shipping; Ga-68 (~68 minutes) and Ac-225 demand on-site or regional generation.

Does the FDA accept radiopharmaceutical data generated in Latin America?

Yes. The FDA accepts outside-US data under 21 CFR 312.120 (drugs/biologics) and 21 CFR 812.28 (device-paired diagnostics) when the study meets ISO 14155 (devices) or ICH E6 GCP (drugs) and the FDA can validate the data. bioaccess® designs radiopharmaceutical programs around a U.S. Pre-Submission so the data supports the intended IND/IDE pathway.

Which isotopes and indications does bioaccess® support?

bioaccess® supports Lu-177, Ac-225, and Ga-68 radioligand and theranostic programs, with dedicated nuclear-medicine sites across its Latin American network. Common indications include oncology theranostics (e.g. PSMA, SSTR) where imaging and therapy use the same molecular target.