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Large phase II trials of fluorescence and reflec- tance spectroscopy using a fiber optic probe in the screen- ing and diagnostic settings for detecting cervical neoplasia have been conducted. We present accrual and histopathol- ogy data, instrumentation, data processing, and the prelimi- nary results of interdevice consistencies throughout the pro- gression of a trial. Patients were recruited for either a screening trial no history of abnormal Papanicolaou smears or a diagnostic trial a history of abnormal Papani- colaou smears. Colposcopy identified normal and abnor- mal squamous, columnar, and transformation zone areas that were subsequently measured with the fiber probe and biopsied. In the course of the clinical trial, two generations of spectrometers FastEEM2 and FastEEM3 were designed and utilized as optical instrumentation for in vivo spectro- scopic fluorescence and reflectance measurements. Data processing of fluorescence and reflectance data is explained in detail and a preliminary analysis of the variability across each device and probe combination is explored. One thou- sand patients were recruited in the screening trial and 850 patients were recruited in the diagnostic trial. Three clinical sites attracted a diverse range of patients of different ages, ethnicities, and menopausal status. The fully processed re- sults clearly show that consistencies exist across all device and probe combinations throughout the diagnostic trial. Based on the stratification of the data, the results also show identifiable differences in mean intensity between normal and high-grade tissue diagnosis, pre- and postmenopausal status, and squamous and columnar tissue type. The mean intensity values of stratified data show consistent separation across each ofthe device and probe combinations. By ana- lyzing trial spectra, we provide more evidence that bio- graphical variables such as menopausal status as well as tissue type and diagnosis significantly affect the data. Under- standing these effects will lead to better modeling param- eters when analyzing the performance of fluorescence and reflectance spectroscopy. © 2007 Society of Photo-Optical Instrumen-

journal of biomedical optics

Fluorescence and reflectance device variability throughout the progression of a phase II clinical trial to detect and screen for cervical neoplasia using a fiber optic probe