P D Mozley1, L H Schwartz2, C Bendtsen3, B Zhao2, N Petrick4, A J Buckler5. 1. Department of Imaging, Merck Research Laboratories, West Point, PA. Electronic address: mozley@merck.com. 2. Department of Radiology, Columbia University, New York, NY, USA. 3. Department of Applied Computer Science and Mathematics, Merck Research Laboratories, Rome, Italy. 4. Center for Devices and Radiological Health, USA Food and Drug Administration, Silver Spring, MD. 5. Buckler Biomedical, LLC, Boston, MA, USA.
Abstract
SPECIFIC AIM: To review the evidence indicating that volumetric image analysis of computed tomography scans meets specifications for qualification as a biomarker in clinical trials or the management of individual patients with lung cancer. METHODS: Claims of value were broken down into questions about technical feasibility, accuracy, the precision of measurement, sensitivity, the correlations with health outcomes, and the risks of producing misleading information. For each claim, the pertinent literature was reviewed. RESULTS: Technical feasibility has now been shown, but only in limited contexts. Accuracy has been demonstrated, but only for tumors with favorable anatomical features. Measurement error still makes the assessment of change in small nodules precarious in diagnostic settings unless rigorous image acquisition and analysis procedures are followed. Precision is sufficient in some larger masses to make volumetrics a sensitive biomarker. In a few trials, correlations with clinical outcomes have been higher for volumetric-based measures than for unidimensional or bidimensional diameters. Value in clinical practice settings and clinical trials has been suggested, but not proven. CONCLUSION: The weight of the evidence indicates there are circumstances in which volumetric image analysis adds value to clinical trial science and the practice of medicine.
SPECIFIC AIM: To review the evidence indicating that volumetric image analysis of computed tomography scans meets specifications for qualification as a biomarker in clinical trials or the management of individual patients with lung cancer. METHODS: Claims of value were broken down into questions about technical feasibility, accuracy, the precision of measurement, sensitivity, the correlations with health outcomes, and the risks of producing misleading information. For each claim, the pertinent literature was reviewed. RESULTS: Technical feasibility has now been shown, but only in limited contexts. Accuracy has been demonstrated, but only for tumors with favorable anatomical features. Measurement error still makes the assessment of change in small nodules precarious in diagnostic settings unless rigorous image acquisition and analysis procedures are followed. Precision is sufficient in some larger masses to make volumetrics a sensitive biomarker. In a few trials, correlations with clinical outcomes have been higher for volumetric-based measures than for unidimensional or bidimensional diameters. Value in clinical practice settings and clinical trials has been suggested, but not proven. CONCLUSION: The weight of the evidence indicates there are circumstances in which volumetric image analysis adds value to clinical trial science and the practice of medicine.
Authors: Mizuki Nishino; Adrian G Sacher; Leena Gandhi; Zhao Chen; Esra Akbay; Andriy Fedorov; Carl F Westin; Hiroto Hatabu; Bruce E Johnson; Peter Hammerman; Kwok-Kin Wong Journal: Eur J Radiol Date: 2016-12-26 Impact factor: 3.528
Authors: Andrew J Buckler; David Paik; Matt Ouellette; Jovanna Danagoulian; Gary Wernsing; Baris E Suzek Journal: J Digit Imaging Date: 2013-08 Impact factor: 4.056
Authors: P David Mozley; Claus Bendtsen; Binsheng Zhao; Lawrence H Schwartz; Matthias Thorn; Yuanxin Rong; Luduan Zhang; Andrea Perrone; René Korn; Andrew J Buckler Journal: Transl Oncol Date: 2012-02-01 Impact factor: 4.243
Authors: C G Vos; M Dahele; J R van Sörnsen de Koste; S Senan; I Bahce; M A Paul; E Thunnissen; E F Smit; K J Hartemink Journal: Strahlenther Onkol Date: 2013-12-22 Impact factor: 3.621