Implementing diffusion-weighted MRI for body imaging in prospective multicentre trials: current considerations and future perspectives

• Published in: European radiology Vol. 28; no. 3; pp. 1118 - 1131
• Main Authors: deSouza, N. M., Winfield, J. M., Waterton, J. C., Weller, A., Papoutsaki, M.-V., Doran, S. J., Collins, D. J., Fournier, L., Sullivan, D., Chenevert, T., Jackson, A., Boss, M., Trattnig, S., Liu, Y.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-03-2018; Springer Nature B.V
• Subjects: Archiving; Biomarkers; Clinical trials; Data acquisition; Data collection; Data processing; Diagnostic Radiology; Diffusion; Diffusion coefficient; Diffusion Magnetic Resonance Imaging - methods; Diffusion Magnetic Resonance Imaging - standards; Disease detection; Disease Progression; Healthy Volunteers; Humans; Image detection; Imaging; Internal Medicine; Interventional Radiology; Magnetic Resonance; Magnetic resonance imaging; Medicine; Medicine & Public Health; Multicenter Studies as Topic; Neoplasms - diagnostic imaging; Neuroradiology; Prognosis; Prospective Studies; Quality assurance; Quality Assurance, Health Care; Quality control; Quantitative analysis; Radiology; Reproducibility; Reproducibility of Results; Software; Subjective assessment; Tumors; Ultrasound; Multicentre trials; Quality assurance; Quantitation; Diffusion-weighted MRI; Standardization
• ISSN: 0938-7994; 1432-1084
• DOI: 10.1007/s00330-017-4972-z

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.
Key Points
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Standardised acquisition
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analysis allows quantification of imaging biomarkers in multicentre trials
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Establishing
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precision
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of the measurement in the multicentre context is essential
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A repository with traceable data of known provenance promotes further research
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