Universität zu Köln

Wolters, E. E., Dodich, A., Boccardi, M., Corre, J., Drzezga, A., Hansson, O., Nordberg, A., Frisoni, G. B., Garibotto, V and Ossenkoppele, R. (2021). Clinical validity of increased cortical uptake of [F-18]flortaucipir on PET as a biomarker for Alzheimer's disease in the context of a structured 5-phase biomarker development framework. Eur. J. Nucl. Med. Mol. Imaging, 48 (7). S. 2097 - 2110. NEW YORK: SPRINGER. ISSN 1619-7089

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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 [F-18]flortaucipir PET and define its research priorities. Methods The level of maturity of [F-18]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. [F-18]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 [F-18]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 [F-18]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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Wolters, E. E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dodich, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Boccardi, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Corre, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Drzezga, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hansson, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nordberg, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Frisoni, G. B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Garibotto, V UNSPECIFIED UNSPECIFIED UNSPECIFIED Ossenkoppele, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-600417
DOI:	10.1007/s00259-020-05118-w
Journal or Publication Title:	Eur. J. Nucl. Med. Mol. Imaging
Volume:	48
Number:	7
Page Range:	S. 2097 - 2110
Date:	2021
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1619-7089
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Radiology, Nuclear Medicine & Medical Imaging Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/60041