Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-01 @ 1:41 PM
Study NCT ID:
NCT00511758
Status:
TERMINATED
Last Update Posted:
2012-08-01
First Post:
2007-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Imaging Aid for Assessment of Cervical Dysplasia
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual rate.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: