Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing ‘translational gaps’ through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored ‘roadmap’. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use.

No abstract

Diffusion-weighted magnetic resonance imaging (DW-MRI) provides image contrast through measurement of the diffusion properties of water within tissues. Application of diffusion sensitising gradients to the MR pulse sequence allows water molecular displacement over distances of 1-20 µm to be recognised. Diffusion can be predominantly unidirectional (anisotropic) or not (isotropic). Combining images obtained with different amounts of diffusion weighting provides an apparent diffusion coefficient (ADC) map. In cancer imaging DW-MRI has been used to distinguish brain tumours from peritumoural oedema. It is also increasingly exploited to differentiate benign and malignant lesions in liver, breast and prostate where increased cellularity of malignant lesions restricts water motion in a reduced extracellular space. It is proving valuable in monitoring treatment where changes due to cell swelling and apoptosis are measurable as changes in ADC at an earlier stage than subsequent conventional radiological response indicators.