Brief Title
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
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.
Study Type
Interventional
Primary Outcome
Detection of precancerous cervical lesions or cervical cancer
Condition
Carcinoma in Situ of Uterine Cervix
Intervention
Multispectral Digital Colposcope with probe
Study Arms / Comparison Groups
Routine colposcopy and MDC with probe
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
618
Start Date
March 2015
Completion Date
December 2017
Primary Completion Date
December 2016
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Michele Follen, MD, PhD, 718-240-8225, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02406352
Organization ID
14-35
Responsible Party
Principal Investigator
Study Sponsor
Brookdale University Hospital Medical Center
Study Sponsor
Michele Follen, MD, PhD, Principal Investigator, Brookdale University Hospital and Medical Center
Verification Date
April 2015