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Comparison of central and local serial CT assessments of metastatic renal cell carcinoma patients in a clinical phase IIB study

: Felsch, M.; Zaim, S.; Dicken, V.; Lehmacher, W.; Scheuring, U.J.


Acta radiologica 58 (2017), No.2, pp.249-255
ISSN: 0284-1851
ISSN: 1600-0455
ISSN: 0001-6926
Journal Article
Fraunhofer MEVIS ()

Background: Clinical oncological studies attempt to improve precision of data by central radiological assessments. However, it is unclear, to which extent local and central assessments diverge.
Purpose: To quantify inter-reader variability and the deviation of local from central radiological assessments of computed tomography (CT) scans.
Material and Methods: This was a sub-study of a randomized clinical phase IIb trial in metastatic renal cell carcinoma (RCC), comparing first-line sorafenib with interferon-alpha-2a (IFN-alpha-2a). It analyzed agreements of local with central RECIST CT assessments by Cohen's kappa (kappa), symmetry tests, deviations in waterfall plots, Bland-Altman plots, and parametric survival analyses.
Conclusion: These data suggest that central radiologic review may reduce technical measurement variability in clinical trials, which should be scrutinized in future studies compared to a volumetric reference.