Suchergebnisse

The application of absolute quantification in SPECT/CT has seen increased interest in the context of radionuclide therapies where patient-specific dosimetry is a requirement within the European Union (EU) legislation. However, the translation of this technique to diagnostic nuclear medicine outside this setting is rather slow. Clinical research has, in some examples, already shown an association between imaging metrics and clinical diagnosis, but the applications, in general, lack proper validation because of the absence of a ground truth measurement. Meanwhile, additive manufacturing or 3D printing has seen rapid improvements, increasing its uptake in medical imaging. Three-dimensional printed phantoms have already made a significant impact on quantitative imaging, a trend that is likely to increase in the future. In this review, we summarize the data of recent literature to underpin our premise that the validation of diagnostic applications in nuclear medicine using application-specific phantoms is within reach given the current state-of-the-art in additive manufacturing or 3D printing.

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. ; Development of this roadmap received support from Cancer Research UK and the Engineering and Physical Sciences Research Council (grant references A/15267, A/16463, A/16464, A/16465, A/16466 and A/18097), the EORTC Cancer Research Fund, and the Innovative Medicines Initiative Joint Undertaking (grant agreement number 115151), resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and European Federation of Pharmaceutical Industries and Associations (EFPIA) companies' in kind contribution.