Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia

NCT ID: NCT02406352

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 618 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-12-31

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.

Conditions

Carcinoma in Situ of Uterine Cervix; Cervical Intraepithelial Neoplasias; High Grade Cervical Intraepithelial Neoplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Routine colposcopy and MDC with probe

The intervention which consists of obtaining cervical images with the MDC and spectroscopic data with the probe will be applied to all participants who agreed to participate in the study during their visit for a colposcopy exam or treatment with a LEEP procedure. A control biopsy will also be obtained from patients who agree to provide it. The control biopsy is a biopsy of cervical tissue that does not appear to have atypical changes when observed through a standard of care colposcope.

Group Type: EXPERIMENTAL

Multispectral Digital Colposcope with probe

Intervention Type: DEVICE

Cervical images will be obtained with the Multispectral Digital Colposcope. Spectroscopic data will be obtained with the probe from eligible patients who provided consent to participate in the study.

The standard of care for research participants will not change.

Interventions

Multispectral Digital Colposcope with probe

Cervical images will be obtained with the Multispectral Digital Colposcope. Spectroscopic data will be obtained with the probe from eligible patients who provided consent to participate in the study.

The standard of care for research participants will not change.

Intervention Type: DEVICE

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

• Women who have had a hysterectomy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brookdale University Hospital Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michele Follen

Chair of Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Follen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brookdale University Hospital and Medical Center

Locations

Brookdale University Hospital and Medical Center

Brooklyn, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leonid Fradkin, PhD

Role: CONTACT

lfradkin@bhmcny.org

718-240-8225

Thelma Carrillo, MPH

Role: CONTACT

tcarrill@bhmcny.org

718-240-5978

Facility Contacts

Leonid Fradkin, PhD

Role: primary

lfradkin@bhmcny.org

718-240-8225

Thelma Carrillo, MPH

Role: backup

tcarrill@bhmcny.org

718-240-5978

Other Identifiers

14-35

Identifier Type: -

Identifier Source: org_study_id