TY - JOUR
T1 - The RSNA QIBA Profile for Amyloid PET as an Imaging Biomarker for Cerebral Amyloid Quantification
AU - Smith, Anne M.
AU - Obuchowski, Nancy A.
AU - Foster, Norman L.
AU - Klein, Gregory
AU - Mozley, P. David
AU - Lammertsma, Adriaan A.
AU - Wahl, Richard L.
AU - Sunderland, John J.
AU - Vanderheyden, Jean-Luc
AU - Benzinger, Tammie L. S.
AU - Kinahan, Paul E.
AU - Wong, Dean F.
AU - Perlman, Eric S.
AU - Minoshima, Satoshi
AU - Matthews, Dawn
N1 - Funding Information: This work was financially supported by the RSNA including QIBA leadership and staff time. This project was funded in whole or in part with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, and Department of Health and Human Services, under contracts HHSN268201300071C, HHSN268201500021C, P50AG005681, P01AG003991, U19AG03243808, U01AG042791, and UL1T R000448. No other potential conflict of interest relevant to this article was reported. The QIBA PET amyloid biomarker committee members who developed and wrote the profile are all volunteers and come from academic, clinical, government, and industry sectors. Without their expertise, experience, time, and effort, the creation of the profile and the advancement of quantitative PET amyloid imaging would not be possible. Dr. Rathan Subramaniam and his team performed the meta-analysis work for the claim. We are grateful to the Imaging Research Laboratory at the University of Washington, Department of Radiology, and Dr. Larry Pierce and Darrin Byrd for spending countless hours developing the PET brain DRO—a major achievement for the profile and the PET amyloid field. Dr. Rachid Fahmi from Siemens Healthineers was instrumental in testing and improving the DRO. Julie Lisieki coordinated all working group meetings and provided documentation supporting profile development, with additional support from Joseph Koudelik. The reviewer of this article made it a stronger publication through helpful criticisms and insights. Finally, we thank the QIBA biomarker committee that authored the 18F-FDG PET/CT as an imaging biomarker measuring response and the Cancer Therapy profile for developing the PET base profile and supporting this committee. Funding Information: This work was financially supported by the RSNA including QIBA leadership and staff time. This project was funded in whole or in part with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, and Department of Health and Human Services, under contracts HHSN268201300071C, HHSN268201500021C, P50AG005681, P01AG003991, U19AG03243808, U01AG042791, and UL1T R000448. No other potential conflict of interest relevant to this article was reported. Publisher Copyright: COPYRIGHT © 2023 by the Society of Nuclear Medicine and Molecular Imaging.
PY - 2023/2/1
Y1 - 2023/2/1
N2 - A standardized approach to acquiring amyloid PET images increases their value as disease and drug response biomarkers. Most 18F PET amyloid brain scans often are assessed only visually (per regulatory labels), with a binary decision indicating the presence or absence of Alzheimer disease amyloid pathology. Minimizing technical variance allows precise, quantitative SUV ratios (SUVRs) for early detection of b-amyloid plaques and allows the effectiveness of antiamyloid treatments to be assessed with serial studies. Methods: The Quantitative Imaging Biomarkers Alliance amyloid PET biomarker committee developed and validated a profile to characterize and reduce the variability of SUVRs, increasing statistical power for these assessments. Results: On achieving conformance, sites can justify a claim that brain amyloid burden reflected by the SUVR is measurable to a within-subject coefficient of variation of no more than 1.94% when the same radiopharmaceutical, scanner, acquisition, and analysis protocols are used. Conclusion: This overview explains the claim, requirements, barriers, and potential future developments of the profile to achieve precision in clinical and research amyloid PET imaging.
AB - A standardized approach to acquiring amyloid PET images increases their value as disease and drug response biomarkers. Most 18F PET amyloid brain scans often are assessed only visually (per regulatory labels), with a binary decision indicating the presence or absence of Alzheimer disease amyloid pathology. Minimizing technical variance allows precise, quantitative SUV ratios (SUVRs) for early detection of b-amyloid plaques and allows the effectiveness of antiamyloid treatments to be assessed with serial studies. Methods: The Quantitative Imaging Biomarkers Alliance amyloid PET biomarker committee developed and validated a profile to characterize and reduce the variability of SUVRs, increasing statistical power for these assessments. Results: On achieving conformance, sites can justify a claim that brain amyloid burden reflected by the SUVR is measurable to a within-subject coefficient of variation of no more than 1.94% when the same radiopharmaceutical, scanner, acquisition, and analysis protocols are used. Conclusion: This overview explains the claim, requirements, barriers, and potential future developments of the profile to achieve precision in clinical and research amyloid PET imaging.
KW - Alzheimer disease
KW - QIBA
KW - amyloid PET
KW - guidelines
KW - quantitative imaging biomarkers
UR - http://www.scopus.com/inward/record.url?scp=85147235692&partnerID=8YFLogxK
U2 - https://doi.org/10.2967/jnumed.122.264031
DO - https://doi.org/10.2967/jnumed.122.264031
M3 - Article
C2 - 36137760
SN - 0161-5505
VL - 64
SP - 294
EP - 303
JO - Journal of nuclear medicine
JF - Journal of nuclear medicine
IS - 2
ER -