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NCT00511758 Clinical Trial

Digital Imaging Aid for Assessment of Cervical Dysplasia

Cervical Dysplasia Clinical Trial

Official title:
Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00511758
Other study ID # 2007-0230
Secondary ID
Status Terminated
Phase N/A
First received August 2, 2007
Last updated July 31, 2012
Start date June 2007
Est. completion date May 2009

Study information
Verified date July 2012
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Digital Imaging
Images of the cervix will be taken using different types of light and compared with the colposcopy procedure.

Locations
Country Name City State
United States U.T.M.D. Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue. 2 Year No
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