Clinical trial NCT02406352: Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia
Official title: Development and Application of a Multispectral Digital Colposcope and Probe Algorithm for Detection of Cervical Intraepithelial Neoplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma in Situ of Uterine Cervix
Cervical Intraepithelial Neoplasias
High Grade Cervical Intraepithelial Neoplasia
Lead sponsor: Brookdale University Hospital Medical Center
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 618
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women who are at least 18 years old
* Are not pregnant (negative urine test) or breastfeeding
* Referred for colposcopy or LEEP treatment
* Can provide written informed consent

Exclusion Criteria:

* Women who do not meet the inclusion criteria
* Women who have had a hysterectomy

Primary outcomes:
measure: Detection of precancerous cervical lesions or cervical cancer
timeFrame: At point of care for colposcopy or treatment with LEEP (5 minutes).
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brookdale University Hospital and Medical Center
state: New York
Study officials:
affiliation: Brookdale University Hospital and Medical Center
name: Michele Follen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: