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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
Sponsor:
Information provided by (Responsible Party):
Michele Follen, Brookdale University Hospital Medical Center

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.

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

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  (Clinical Trial)
Estimated Enrollment : 618 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Leonid Fradkin, PhD 718-240-8225 lfradkin@bhmcny.org
Contact: Thelma Carrillo, MPH 718-240-5978 tcarrill@bhmcny.org

Locations
United States, New York
Brookdale University Hospital and Medical Center Recruiting
Brooklyn, New York, United States, 11212
Contact: Leonid Fradkin, PhD    718-240-8225    lfradkin@bhmcny.org   
Contact: Thelma Carrillo, MPH    718-240-5978    tcarrill@bhmcny.org   
Principal Investigator: Michele Follen, MD, PhD         
Sponsors and Collaborators
Brookdale University Hospital Medical Center
Investigators
Principal Investigator: Michele Follen, MD, PhD Brookdale University Hospital and Medical Center

Additional Information:
Responsible Party: Michele Follen, Chair of Department of Obstetrics and Gynecology, Brookdale University Hospital Medical Center
ClinicalTrials.gov Identifier: NCT02406352     History of Changes
Other Study ID Numbers: 14-35
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type