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


N/A
18 Years
N/A
Not Enrolling
Female
Cervical Dysplasia

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue.

Outcome Time Frame:

2 Year

Safety Issue:

No

Principal Investigator

Michele Follen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0230

NCT ID:

NCT00511758

Start Date:

June 2007

Completion Date:

May 2009

Related Keywords:

  • Cervical Dysplasia
  • Cervical Dysplasia
  • Digital Imaging
  • Colposcopy
  • Cervix
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia
  • Hyperplasia

Name

Location

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