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.

Large phase II trials of fluorescence and reflectance spectroscopy using a fiber optic probe in the screening and diagnostic settings for detecting cervical neoplasia have been conducted. We present accrual and histopathology data, instrumentation, data processing, and the preliminary results of interdevice consistencies throughout the progression 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 Papanicolaou smears).

Instrumentation as a source of variability in the application of fluorescence spectroscopic devices for detecting cervical neoplasia.

We report on a study designed to assess variability among three different fluorescence spectroscopy devices, four fiber optic probes, and three sets of optical calibration standards to better understand the reproducibility of measurements and interdevice comparisons of fluorescence spectroscopic data intended for clinical diagnostic use. Multiple measurements are acquired from all sets of standards using each combination of spectrometer, fiber optic probe, and optical standard. Data are processed using standard calibration methods to remove instrument-dependant responses.

Design and preliminary analysis of a study to assess intra-device and inter-device variability of fluorescence spectroscopy instruments for detecting cervical neoplasia.

Introduction: A study was designed to assess variability between different fluorescence spectroscopy devices. Measurements were made with all combinations of three devices, four probes, and three sets of standards trays. Additionally, we made three measurements on the same day over 2 days for the same combination of device, probe, and standards tray to assess reproducibility over a day and across days.