High Grade Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
Development and Application of a Multispectral Digital Colposcope and Probe Algorithm for Detection of Cervical Intraepithelial Neoplasia
Although cervical cancer is a preventable cancer, every year more than one-quarter of a million women die worldwide from this disease. Internationally and nationally, cervical cancer is a disease that affects predominantly women who are poor and who live in resource poor settings. With the device the investigators are developing, known as the Multispectral Digital Colposcope with probe, our goal is to make detection of precancerous cervical lesions easier for the patient and for her provider. For the patient, our goal is to reduce the number of clinical visits needed to obtain a diagnosis and treatment and consequently to reduce the resulting fear and anxiety which usually accompanies an abnormal Pap smear. For the provider and the health care system, our goal is to obtain a more accurate diagnosis than the currently available diagnostic methods.
The multispectral digital colposcope (MDC) is a specialized lightsource and imaging device
mounted on a custom-made colposcope that acquires a sequence of fluorescence images. This
version of the MDC incorporates an upgraded light source, and updates the firmware and the
user interface. This results in shorter acquisition times and improved image and spectrum
quality control. The MDC also consists of a point probe that is used to take detailed light
measurements (call spectroscopy) from smaller regions of the cervix. The goal of the study
is to see whether the MDC can perform better than standard methods in detecting cancerous or
pre-cancerous abnormalities of the cervix.
Study subjects will be swabbed for detection and typing of the Human Papilloma Virus (HPV).
After vinegar is applied on the cervix as per usual colposcopy practice, the MDC will then
be used to take a sequence of images of the cervix. Next 2-4 readings will be taken from the
cervix using the point probe.
This data will be used to train, test and validate an algorithm specific to the MDC. The
ability of the algorithm to detect cervical intraepithelial neoplasia will be compared to
standard clinical care (colposcopy).
The MDC images and pathology results will be compared to the spectroscopy data from the MDC
probe. The investigators will determine if spectroscopy has equal sensitivity to colposcopy
for detecting high grade lesions.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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