title: A novel measurement technique to assess the effects of coronary brachytherapy in clinical trials.
abstract: This paper presents a novel measurement technique to assess the effects of coronary brachytherapy. This new technique is based upon the conventional quantitative coronary analysis (QCA) technique, which is accepted worldwide as an accurate and reliable analysis tool for clinical trials. This paper provides the definitions and main issues important for correct brachytherapy analysis. Based on these definitions, this novel technique is implemented as an extension of conventional QCA software, as a multisegmental analysis tool. It allows to follow the influence of radiation on restenosis, and the mutual relation between intervention devices. A pilot interobserver study was performed to assess the reliability and reproducibility of the brachytherapy analysis tool, using 15 patient cases. The validation results show that the segment lengths, minimum lumen diameter, and reference diameters of the user-defined and derived (sub)segments can be assessed reproducible. However, these good results can only be obtained, when strict and extensive image acquisition and image analysis protocols are followed. From this pilot validation study presented in this paper and only based on a small number of patients, we may conclude that the software can be applied to clinical trials.
authors.affiliation: Division of Image Processing (LKEB), Department of Radiology, Building I C2-S, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands. g.koning@lumc.nl
authors.forename: Gerhard
authors.initials: G
authors.lastname: Koning
authors.forename: Joan C
authors.initials: JC
authors.lastname: Tuinenburg
authors.forename: Ellen
authors.initials: E
authors.lastname: Hekking
authors.forename: Janny
authors.initials: J
authors.lastname: Peelen
authors.forename: Anton W M
authors.initials: AW
authors.lastname: van Weert
authors.forename: Danny
authors.initials: D
authors.lastname: Bergkamp
authors.forename: Bob
authors.initials: B
authors.lastname: Goedhart
authors.forename: Johan H C
authors.initials: JH
authors.lastname: Reiber
mesh_terms: D001918:Brachytherapy / Q000379:methods / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D017023:Coronary Angiography / Q000379:methods* / Q000592:standards*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000209:etiology / Q000517:prevention & control / Q000532:radiotherapy*; D006801:Humans; D007090:Image Interpretation, Computer-Assisted / Q000379:methods* / Q000592:standards; D015588:Observer Variation; D010865:Pilot Projects; D011856:Radiographic Image Enhancement / Q000379:methods; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016896:Treatment Outcome