Optical technologies and molecular imaging for cervical neoplasia: a program project update.

There is an urgent global need for effective and affordable approaches to cervical cancer screening and diagnosis. In developing nations, cervical malignancies remain the leading cause of cancer-related deaths in women. This reality may be difficult to accept given that these deaths are largely preventable; where cervical screening programs have been implemented, cervical cancer-related deaths have decreased dramatically.

Repeatability of tissue fluorescence measurements for the detection of cervical intraepithelial neoplasia.

We examined intensity and shape differences in 378 repeated spectroscopic measures of the cervix. We examined causes of variability such as presence of precancer or cancer, pathologic tissue type, menopausal status, hormone or oral contraceptive use, and age; as well as technology related variables like generation of device and provider making exam. Age, device generation, and provider were statistically significantly related to intensity differences.

Sources of variability in fluorescence spectroscopic measurements in a Phase II clinical trial of 850 patients.

Background: Devices using fluorescence spectroscopy to differentiate high grade squamous intraepithelial lesions from normal tissue in the cervix have shown some diagnostic efficacy. Measurements from these devices produce large amounts of complex, multi-factored data. The purpose of this study is to isolate the effects of the particular care providers and equipment operators who are involved in taking measurements.

Methodology of a real-time quality control for the multispectral digital colposcope (MDC).

Background: The diagnostic ability of algorithms developed for the Multispectral Digital Colposcope (MDC) is highly dependent on the quality of the image. The field of objective medical image quality analysis has great potential but has not been well exploited. Various researchers have reported different measures of image quality but with an existence of a reference image.

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.