Securing and optimizing ¹⁸f-dcfpyl dispensing through automation: stability, dosimetry and operational performance

Authors: S. Journo (1), R. Bodin (1), T. Rusu (1)

(1) Nuclear Medicine, Radiopharmacy Unit, GH AP-HP Sorbonne University, Tenon Hospital, Paris, France

The radiopharmacy unit of the Nuclear Medicine Department at Tenon Hospital, part of GH AP-HP Sorbonne University, evaluated automated ¹⁸F-DCFPyL dispensing across three areas: product stability, operator dosimetry and dose accuracy. The results were presented at SOFRA 2026.

A need for standardization and automation

As PET imaging expands and new radiopharmaceuticals reach the clinic, standardizing preparation and dispensing practices is becoming essential.

New molecules keep arriving: PSMA tracers, somatostatin analogues, FAPI ligands, amyloid tracers. Each new product requires the unit to develop and validate new operating procedures, train operators and reassess radiation exposure.

For ¹⁸F-FDG, automated dispensing has already demonstrated several benefits: lower operator exposure, improved traceability, faster preparation and fewer human errors. The same challenges now apply to newer tracers.

¹⁸F-DCFPyL, marketed as Pylclari® by Curium, targets PSMA, a protein that is overexpressed by prostate cancer cells.

The study

The radiopharmacy unit compared two ¹⁸F-DCFPyL dispensing methods:

automated dispensing using Unidose®
manual dispensing in a shielded hot cell

The initial activity was approximately 2,100 MBq in both cases. Samples were collected at T0, 3 hours and 6 hours. Three areas were evaluated: stability and quality control, operator dosimetry and operational performance.

The tests followed the tracer manufacturer’s recommendations and included appearance, pH, radiochemical purity assessed by TLC and radio-HPLC, sterility and endotoxin testing in accordance with the European Pharmacopoeia.

The authors’ conclusions

The study supports the routine use of automated ¹⁸F-DCFPyL dispensing. The authors reported improved radiation protection, greater standardization of dose preparation and a more efficient PET workflow:

Pylclari® quality remained stable for 6 hours, both in the original vial and in the Unidose® kit
Major reduction in operator exposure: -99.15% to the extremities (average of both hands) and -70.6% to the whole body
Significant reduction in preparation time: -86.5%
Greater accuracy and reproducibility of the delivered doses, with variability reduced by 51%
A safer and more efficient dispensing workflow

Transferability and impact on the PET workflow

The authors consider the method transferable to other fluorine-18 or gallium-68 radiopharmaceuticals.

They also note that combining automated dispensing with dose transfer through a tunnel frees up time for technologists. That freed capacity could be used to perform more examinations and shorten patient waiting times.

Read the poster (PDF)

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Disclaimer

These results were obtained at one center, using one tracer and under the specific conditions of the study. They do not constitute an equipment performance specification.

Automated dispensing of ¹⁸F-DCFPyL with Unidose