WP1: Establishment of traceability routes

Current state of the art

  • Not all NMI/DIs in Europe maintain primary standards of radioactivity
  • Access to radioactivity standards in hospitals varies across Europe
  • Clinical users reliant on non-traceable manufacturer supplied settings
  • Low engagement between end-users and metrology communities.

Beyond state of the Art (D1/D2)

  • Establish traceability routes in partner countries for important radionuclides
  • Create framework through guidance to expand networks internationally
  • Engage with users to facilitate uptake

 


WP2: Assessing Uncertainty

Current state of the art

  • No uncertainties = no traceability
  • Unknown accuracy in administrations
  • Unknown accuracy in activities derived from images and dosimetry calculations
  • Low engagement of clinical community with metrology community

Beyond state of the Art (D3/D4)

  • Enable traceability routes to be created by incorporating uncertainties
  • Determine current capability and highlight areas requiring improvement
  • Engage with community to ensure uncertainties are a routine part of measurement

 

 

WP3: Validation of effectiveness

Current state of the art

  • Comparison exercises in nuclear medicine not performed routinely
  • Measurement capability in hospitals largely unknown across Europe
  • Minimal guidance available on how to perform comparison exercises

Beyond state of the Art (D1/D2)

  • Perform comparisons to assess effectiveness of new calibration routes
  • Create guidance to improve quality and quantity of comparison exercises performed in nuclear medicine.
  • Deliver training and advice to end users on importance of traceability
  • Enable future expansion of traceability

 


WP4: Creating Impact

Stakeholder and Industry Support

Seven technical deliverables

Communication and dissemination:

  • Website, Newsletters, Social Media
  • Stakeholder Committee, 4 workshops
  • Engagement with societies & conferences
  • Three guidance documents, at least two publications & training material

Exploitation:

  • Uptake of outputs by hospitals, equipment manufacturers, radiopharmaceutical industry…
  • Upskilling the workforce through training

Outcomes for Industry & others

  • New calibration services available
  • Protocols for establishing traceability
  • Guidance on uncertainty estimation
  • Facilitate CMC claims

Standards and Compliance:

  • Support compliance with regulations (EC Directives 2013/59/EURATOM, 2001/83/EC and 2001/20/EC)
  • International uptake of outputs by IAEA, EANM, EFOMP & NM Societies
  • Establish new networks & collaborations

Long Term Impact

Economic/technical:

  • New calibration services from NMI/DIs creating traceability networks improving capability & harmonisation across Europe
  • Improved accuracy of therapeutic and diagnostic administrations
  • enabling pooling of data from multicentre clinical trials in NM

Social:

  • Accurate administrations and dosimetry in NM, improving the patient pathway

 


WP5: Management / Coordination / Consortium

9 NMI/DIs:

NPL (Coordinator, UK), VSL (WP1 lead, Netherlands), STUK (WP2 lead, Finland), CMI (WP3 lead, Czechia), FTMC (Lithuania), IST (Portugal), SSM (Sweden), CHUV, METAS (Switzerland).

5 clinical beneficiaries:

Lund (WP4 lead, Sweden), HUS (Finland), VUHSK (Lithuania), KS (Sweden), RSFT (UK).