Steps to standardization and validation of hippocampal volumetry as a biomarker in clinical trials and diagnostic criterion for Alzheimer's disease

被引：161

作者：

Jack, Clifford R., Jr. ^{[1
]}

Barkhof, Frederik

Bernstein, Matt A. ^{[1
]}

Cantillon, Marc ^{[2
]}

Cole, Patricia E. ^{[3
]}

DeCarli, Charles ^{[4
,5
]}

Dubois, Bruno ^{[6
]}

Duchesne, Simon ^{[7
,8
]}

Fox, Nick C. ^{[9
]}

Frisoni, Giovanni B. ^{[10
]}

Hampel, Harald ^{[11
]}

Hill, Derek L. G. ^{[12
,13
]}

Johnson, Keith ^{[14
,15
]}

Mangin, Jean-Francois ^{[16
]}

Scheltens, Philip

Schwarz, Adam J. ^{[17
]}

Sperling, Reisa ^{[18
]}

Suhy, Joyce ^{[19
]}

Thompson, Paul M. ^{[20
]}

Weiner, Michael ^{[21
,22
]}

Foster, Norman L. ^{[23
]}

机构：

[1] Mayo Clin, Dept Radiol, Rochester, MN 55905 USA

[2] Crit Path Inst, Coalit Major Dis, Rockville, MD USA

[3] Imagepace, Cincinnati, OH USA

[4] Univ Calif Davis, Dept Neurol, Sacramento, CA 95817 USA

[5] Univ Calif Davis, Ctr Neurosci, Sacramento, CA 95817 USA

[6] Univ Paris 06, Dept Neurol, Salpetriere Hosp, Paris, France

[7] Ctr Rech Univ Laval Robert Giffard, Dept Radiol, Quebec City, PQ, Canada

[8] Univ Laval, Dept Radiol, Quebec City, PQ, Canada

[9] UCL Inst Neurol, Dementia Res Ctr, London, England

[10] IRCCS San Giovanni di Dio FBF, Lab Epidemiol & Neuroimaging, Brescia, Italy

[11] Goethe Univ Frankfurt, Dept Psychiat Psychosomat Med & Psychotherapy, Frankfurt, Germany

[12] UCL, Dept Med Phys & Bioengn, Ctr Med Image Comp, London, England

[13] IXICO Ltd, London Biosci Innovat Ctr, London, England

[14] Harvard Univ, Brigham & Womens Hosp, Dept Neurol, Sch Med,Ctr Alzheimer Res & Treatment, Boston, MA 02115 USA

[15] Harvard Univ, Massachusetts Gen Hosp, Sch Med, Div Mol Imaging, Boston, MA USA

[16] CEA, I2BM, Saclay, France

[17] Eli Lilly & Co, Translat Med, Indianapolis, IN 46285 USA

[18] Harvard Univ, Brigham & Womens Hosp, Dept Neurol, Sch Med, Boston, MA 02115 USA

[19] Synarc Inc, Div Neurol, San Francisco, CA USA

[20] Univ Calif Los Angeles, Sch Med, Dept Neurol, Lab Neuro Imaging, Los Angeles, CA 90024 USA

[21] VA Med Ctr, Ctr Imaging Neurodegenerat Dis, Dept Vet Affairs, San Francisco, CA USA

[22] Univ Calif San Francisco, Dept Radiol & Biomed Imaging, San Francisco, CA 94143 USA

[23] Univ Utah, Dept Neurol, Ctr Alzheimers Care Imaging & Res, Salt Lake City, UT USA

来源：

ALZHEIMERS & DEMENTIA | 2011年 / 7卷 / 04期

基金：

英国医学研究理事会; 美国国家卫生研究院; 英国工程与自然科学研究理事会;

关键词：

Alzheimer's disease; Biomarkers; Magnetic resonance imaging; Hippocampus; Biomarker standards; MILD COGNITIVE IMPAIRMENT; MEDIAL TEMPORAL ATROPHY; BRAIN ATROPHY; MRI MEASURES; PROBABLE AD; SEGMENTATION; PROGRESSION; CLASSIFICATION; PREDICTORS; DEMENTIA;

D O I：

10.1016/j.jalz.2011.04.007

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background: The promise of Alzheimer's disease biomarkers has led to their incorporation in new diagnostic criteria and in therapeutic trials; however, significant barriers exist to widespread use. Chief among these is the lack of internationally accepted standards for quantitative metrics. Hippocampal volumetry is the most widely studied quantitative magnetic resonance imaging measure in Alzheimer's disease and thus represents the most rational target for an initial effort at standardization. Methods and Results: The authors of this position paper propose a path toward this goal. The steps include the following: ( I) Establish and empower an oversight board to manage and assess the effort, (2) adopt the standardized definition of anatomic hippocampal boundaries on magnetic resonance imaging arising from the European Alzheimer's Disease Centers Alzheimer's Disease Neuroimaging Initiative hippocampal harmonization effort as a reference standard, (3) establish a scientifically appropriate, publicly available reference standard data set based on manual delineation of the hippocampus in an appropriate sample of subjects (Alzheimer's Disease Neuroimaging Initiative), and (4) define minimum technical and prognostic performance metrics for validation of new measurement techniques using the reference standard data set as a benchmark. Conclusions: Although manual delineation of the hippocampus is the best available reference standard, practical application of hippocampal volumetry will require automated methods. Our intent was to establish a mechanism for credentialing automated software applications to achieve internationally recognized accuracy and prognostic performance standards that lead to the systematic evaluation and then widespread acceptance and use of hippocampal volumetry. The standardization and assay validation process outlined for hippocampal volumetry was envisioned as a template that could be applied to other imaging biomarkers. (C) 2011 The Alzheimer's Association. All rights reserved.

引用

页码：474 / 485

页数：12

共 96 条

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