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@ARTICLE{Wolters:904375,
      author       = {Wolters, E. E. and Dodich, A. and Boccardi, M. and Corre,
                      J. and Drzezga, Alexander and Hansson, O. and Nordberg, A.
                      and Frisoni, G. B. and Garibotto, V. and Ossenkoppele, R.},
      title        = {{C}linical validity of increased cortical uptake of
                      [18{F}]flortaucipir on {PET} as a biomarker for
                      {A}lzheimer’s disease in the context of a structured
                      5-phase biomarker development framework},
      journal      = {European journal of nuclear medicine and molecular imaging},
      volume       = {48},
      number       = {7},
      issn         = {0340-6997},
      address      = {Heidelberg [u.a.]},
      publisher    = {Springer-Verl.},
      reportid     = {FZJ-2021-05945},
      pages        = {2097 - 2109},
      year         = {2021},
      abstract     = {Purpose: In 2017, the Geneva Alzheimer's disease (AD)
                      Biomarker Roadmap initiative adapted the framework of the
                      systematic validation of oncological diagnostic biomarkers
                      to AD biomarkers, with the aim to accelerate their
                      development and implementation in clinical practice. With
                      this work, we assess the maturity of [18F]flortaucipir PET
                      and define its research priorities.Methods: The level of
                      maturity of [18F]flortaucipir was assessed based on the AD
                      Biomarker Roadmap. The framework assesses analytical
                      validity (phases 1-2), clinical validity (phases 3-4), and
                      clinical utility (phase 5).Results: The main aims of phases
                      1 (rationale for use) and 2 (discriminative ability) have
                      been achieved. [18F]Flortaucipir binds with high affinity to
                      paired helical filaments of tau and has favorable kinetic
                      properties and excellent discriminative accuracy for AD. The
                      majority of secondary aims of phase 2 were fully achieved.
                      Multiple studies showed high correlations between
                      ante-mortem [18F]flortaucipir PET and post-mortem tau (as
                      assessed by histopathology), and also the effects of
                      covariates on tracer binding are well studied. The aims of
                      phase 3 (early detection ability) were only partially or
                      preliminarily achieved, and the aims of phases 4 and 5 were
                      not achieved.Conclusion: Current literature provides partial
                      evidence for clinical utility of [18F]flortaucipir PET. The
                      aims for phases 1 and 2 were mostly achieved. Phase 3
                      studies are currently ongoing. Future studies including
                      representative MCI populations and a focus on healthcare
                      outcomes are required to establish full maturity of phases 4
                      and 5.Keywords: Alzheimer’s disease; Biomarker-based
                      diagnosis; PET; Strategic roadmap; [18F]flortaucipir.},
      cin          = {INM-2},
      ddc          = {610},
      cid          = {I:(DE-Juel1)INM-2-20090406},
      pnm          = {5253 - Neuroimaging (POF4-525)},
      pid          = {G:(DE-HGF)POF4-5253},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {33547556},
      UT           = {WOS:000615202400001},
      doi          = {10.1007/s00259-020-05118-w},
      url          = {https://juser.fz-juelich.de/record/904375},
}