Digital Imaging Aid for Assessment of Cervical Dysplasia

July 31, 2012 updated by: M.D. Anderson Cancer Center

Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia

The overall objective of this study is to evaluate whether polarized or green filtered digital imaging can assist clinicians to screen for premalignant lesions in the cervix.

The specific aims of the study are:

  • To compare polarized and green filtered digital images of the cervix, to standard white light images, colposcopic evaluation and to pathologic analysis of biopsied tissue.
  • To develop algorithms to discriminate between normal and abnormal tissue based on digital images of the cervix.
  • To analyze digital images to determine which types of optical information yield the most diagnostically useful data.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

If you agree to take part in this study, digital imaging will be performed for research purposes, after your routine colposcopy of your cervix.

VISUAL DETECTION OF PRECANCEROUS LESIONS:

Reflectance (the ability of an area to reflect light) imaging helps doctors visually tell the difference between precancerous tissue, cancerous tissue, and normal tissue in the cervix. Researchers want find out whether a digital camera image can be as effective as colposcopy at screening for precancerous tissue.

STUDY PARTICIPATION:

You will be seen in the clinic during a routine visit. Your cervix will first be examined by the clinician using a standard white light headlamp, and the image will be recorded.

Your cervix will then be re-examined with the digital camera, which will involve the use of different types of light (standard white light, green filtered light, cross and parallel polarized light). These digital images will be taken before and after acetic acid (vinegar) is applied.

Researchers will use these images to make comparison studies with the colposcopy procedure.

LENGTH OF STUDY:

Your participation will be finished on this study once your cervix has been examined with the digital camera.

This is an investigational study. Up to patients 20 will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • U.T.M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.

Description

Inclusion Criteria:

  • Patients 18 years or older who are referred to the University of Texas MD Anderson Cancer Center Colposcopy Clinic for colposcopy are eligible for this study.
  • Patients must sign an informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria:

  • Patients who are pregnant are not eligible for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Digital Imaging Device
Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.
Procedure: Digital Imaging
Images of the cervix will be taken using different types of light and compared with the colposcopy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue.
Time Frame: 2 Year
2 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

August 2, 2007

First Submitted That Met QC Criteria

August 3, 2007

First Posted (Estimate)

August 6, 2007

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0230

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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