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Metrology Standards for Quantitative Imaging Biomarkers.

Daniel C Sullivan1, Nancy A Obuchowski1, Larry G Kessler1

  • 1From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).

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Summary

Quantitative imaging biomarkers (QIBs) development is hindered by inconsistent terminology and methods. Standardizing concepts and technical performance evaluations is crucial for advancing clinical research and patient care.

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Area of Science:

  • Medical Imaging
  • Biomarker Development
  • Quantitative Imaging

Background:

  • Quantitative imaging biomarkers (QIBs) are increasingly developed but face implementation challenges.
  • Inconsistent use of terminology and methods for technical performance and statistical concepts impede QIB progress.

Purpose of the Study:

  • To review statistical concepts relevant to QIB evaluation.
  • To describe methods for evaluating and comparing QIBs.
  • To discuss technical performance issues in imaging biomarkers.

Main Methods:

  • Review of statistical concepts.
  • Description of QIB evaluation and comparison methodologies.
  • Discussion of technical performance aspects.

Main Results:

  • Identified inconsistencies in terminology and methods as key barriers.
  • Presented approaches for evaluating QIB technical performance and statistical validity.

Conclusions:

  • Standardized terminology and robust study design principles are essential.
  • Improved practices will advance regulatory science and enhance patient care through better imaging biomarkers.