Brief Title
Digital Imaging Aid for Assessment of Cervical Dysplasia
Official Title
Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia
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.
Study Type
Observational
Primary Outcome
Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue.
Condition
Cervical Dysplasia
Intervention
Digital Imaging
Study Arms / Comparison Groups
Digital Imaging Device
Description: Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
3
Start Date
June 2007
Completion Date
May 2009
Primary Completion Date
May 2009
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Michele Follen, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00511758
Organization ID
2007-0230
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Michele Follen, MD, PhD, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
July 2012