Nuclear medicine, theranostics and radiopharmacy.

Theranostics links imaging of a biological target with its therapeutic use. This creates requirements for your facility’s imaging, radiopharmaceuticals, staff and treatment capacity. WiseRay supports the establishment and further development of Lu-177 programmes and the specialist assessment of other techniques using Y-90, Ra-223 and Ac-225.

The use of Lu-177 is also evolving. Under defined conditions, the current Swiss product information for Lu-177-PSMA-617 already includes patients for whom taxane-based chemotherapy can be deferred. This broadens the requirements for collaboration between nuclear medicine, oncology and referring specialties.

Phase III programmes are now also under way for Ac-225-PSMA. Clinical development is not, however, equivalent to general Swiss authorisation for routine use. The product, indication and permitted conditions of use must be assessed separately.

A WiseRay project therefore begins with a product- and procedure-specific assessment: which services are planned, what infrastructure is available and which evidence is missing? Determining the medical indication remains the responsibility of the treating physicians. Our role is to assess the medical physics and operational prerequisites transparently.

An administered activity is not an individual organ or tumour dose. The distribution of the radiopharmaceutical, its retention over time and the quality of the measurement and analysis chain are also decisive.

WiseRay examines the relationship between the activity meter, administration records and quantitative imaging. This includes nuclide-specific instrument settings, measurement geometry, time reference, residual activity, calibration and constancy testing. Dosimetry programmes additionally require alignment of activity measurement and camera calibration, acquisition times, reconstruction, segmentation and uncertainty assessment.

The FOPH guidance on radionuclide therapy requires an individual dose calculation determined and documented in advance. The measurements and calculations required are defined for each therapy. A blanket requirement for identical imaging series for every product would be as inappropriate as an unexplained standard activity.

For Ac-225, daughter nuclides, possible redistribution and the limitations of activity quantification must be considered in particular. The 2026 EANM recommendations explicitly address these issues. Lu-177 analysis methods therefore cannot be transferred to alpha therapies without verification.

Our aim is an auditable measurement chain with stated uncertainties. Radiopharmaceutical preparation, ready-to-use administration and pharmaceutical release are kept organisationally separate; product release remains the responsibility of the designated professionals.

In the hot lab and treatment ward, external exposure, skin contamination and possible intake of radioactive substances must be considered together. Appropriate measures depend on the nuclide, task, activity and working methods.

WiseRay examines critical handling steps: drawing up and connecting, administration, handling residual activity, assisting with personal hygiene, cleaning and waste transport. We assess where shielding, aids, prepared materials and shorter handling times are effective. Gloves and protective clothing primarily prevent contamination; they do not replace appropriate shielding.

Personal dosimetry must match the work performed. In addition to whole-body monitoring, extremity dosimetry and monitoring tailored to the risk of intake may be required. A ring dosimeter is only meaningful when its wearing position matches the actual handling technique.

For Ac-225, we additionally assess whether the planned contamination measurement methods adequately detect the relevant nuclide mixture. A low external dose rate alone does not answer this question.

Together with you, we define measurement methods, responsibilities and procedures for abnormal findings. Cleaning staff, technical services and supporting professions are included because their tasks form part of the same material and contamination pathway.

The legal basis for inpatient therapy and discharge is provided by Art. 53 and 55 of the Swiss Ordinance on the Handling of Radioactive Material (UraM). The FOPH guidance on radionuclide therapy dated 24 June 2025 specifies implementation for commonly used nuclides.

For Lu-177 from 1000 MBq, it specifies a minimum hospital stay of 20 hours after administration. Patients are accommodated in an appropriately shielded treatment room connected to the wastewater decay system. The criterion was derived for PSMA and neuroendocrine tumour therapies with administered activities up to 8 GBq. The table does not specify an additional dose-rate criterion for Lu-177.

WiseRay integrates these requirements into practical discharge planning: mobility, continence, support needs, travel home, household circumstances and necessary behavioural instructions. Organisational preparations are also needed for an unplanned transfer or readmission to hospital.

For Ac-225, this FOPH table contains no corresponding general discharge criterion. Conditions must therefore be clarified with the competent authority for the specific treatment programme.

For shortened or alternative treatment pathways, we develop a transparent feasibility assessment. A technical solution for collecting excreta does not replace assessment of the admission and discharge requirements.

Solid residues, contaminated materials and liquid excreta require different documentation and disposal pathways. WiseRay therefore examines not only storage areas and tanks but the complete activity and material balance.

Art. 54 para. 1 UraM treats excreta from inpatients receiving therapy as radioactive material. Art. 26 UraM governs connection of the relevant sanitary facilities to a wastewater monitoring system. Its design under Art. 25 UraM includes at least two collection tanks that can be used alternately; emptying must not be triggered automatically. Art. 37 UraM governs discharge accounting and determination of activity before tank emptying.

For your facility, this means that patient numbers, excretion patterns, water consumption, filling operations, decay time and discharge must be consistent. We also assess misrouting, switching states, alarms, sampling and responsibility for authorising emptying.

For solid materials, decay storage includes a documented pathway through to clearance measurements under Art. 106 of the Swiss Radiological Protection Ordinance (StSV). Origin, nuclides, storage time and measurement results must remain traceable.