Clinical trial NCT00511758: Digital Imaging Aid for Assessment of Cervical Dysplasia
Official title: Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cervical Dysplasia
Keywords: Cervical Dysplasia
Digital Imaging
Colposcopy
Cervix
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-08-06
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue.
timeFrame: 2 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michele Follen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: