Journal
EUROPEAN RADIOLOGY
Volume 28, Issue 3, Pages 1118-1131Publisher
SPRINGER
DOI: 10.1007/s00330-017-4972-z
Keywords
Diffusion-weighted MRI; Multicentre trials; Quality assurance; Quantitation; Standardization
Funding
- EU Innovative Medicines Initiative
- Cruk
- Cancer Research UK [16464, 18097, 16465, 12762] Funding Source: researchfish
- Medical Research Council [G0701533] Funding Source: researchfish
- MRC [G0701533] Funding Source: UKRI
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For body imaging, diffusion-weighted MRI may be used for tumour detection, staging, prognostic information, assessing response and follow-up. Disease detection and staging involve qualitative, subjective assessment of images, whereas for prognosis, progression or response, quantitative evaluation of the apparent diffusion coefficient (ADC) is required. Validation and qualification of ADC in multicentre trials involves examination of i) technical performance to determine biomarker bias and reproducibility and ii) biological performance to interrogate a specific aspect of biology or to forecast outcome. Unfortunately, the variety of acquisition and analysis methodologies employed at different centres make ADC values non-comparable between them. This invalidates implementation in multicentre trials and limits utility of ADC as a biomarker. This article reviews the factors contributing to ADC variability in terms of data acquisition and analysis. Hardware and software considerations are discussed when implementing standardised protocols across multi-vendor platforms together with methods for quality assurance and quality control. Processes of data collection, archiving, curation, analysis, central reading and handling incidental findings are considered in the conduct of multicentre trials. Data protection and good clinical practice are essential prerequisites. Developing international consensus of procedures is critical to successful validation if ADC is to become a useful biomarker in oncology.
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