Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia (MDCwProbe)
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|ClinicalTrials.gov Identifier: NCT02406352|
Recruitment Status : Unknown
Verified April 2015 by Michele Follen, Brookdale University Hospital Medical Center.
Recruitment status was: Recruiting
First Posted : April 2, 2015
Last Update Posted : April 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma in Situ of Uterine Cervix Cervical Intraepithelial Neoplasias High Grade Cervical Intraepithelial Neoplasia||Device: Multispectral Digital Colposcope with probe||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||618 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Application of a Multispectral Digital Colposcope and Probe Algorithm for Detection of Cervical Intraepithelial Neoplasia|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
Experimental: 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.
Device: 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.
- Detection of precancerous cervical lesions or cervical cancer [ Time Frame: At point of care for colposcopy or treatment with LEEP (5 minutes). ]
Eligible patients who are referred to the colposcopy clinic for a diagnosis following an abnormal Pap smear will be asked to participate in the study. All participating women will receive their standard of care colposcopy as usual. In addition to their routine care, the MDC with probe will also be used to collect images of the cervix and spectroscopic measurements with the probe. All measurements will be compared with the biopsies obtained. The MDC with probe will not be used to determine from where the biopsies need to be obtained. One or two additional biopsies will be obtained from tissue that appears to be unaffected. These will be the control biopsies. Patients may refuse to provide the additional biopsies which are not part of the standard of care.
Patients scheduled for a treatment with the Loop Electrosurgical Excision Procedure (LEEP) will be asked for consent to obtain one or two biopsies prior to the LEEP procedure, but after anesthesia has been applied.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406352
|Contact: Leonid Fradkin, PhDfirstname.lastname@example.org|
|Contact: Thelma Carrillo, MPHemail@example.com|
|United States, New York|
|Brookdale University Hospital and Medical Center||Recruiting|
|Brooklyn, New York, United States, 11212|
|Contact: Leonid Fradkin, PhD 718-240-8225 firstname.lastname@example.org|
|Contact: Thelma Carrillo, MPH 718-240-5978 email@example.com|
|Principal Investigator: Michele Follen, MD, PhD|
|Principal Investigator:||Michele Follen, MD, PhD||Brookdale University Hospital and Medical Center|