CClinicalTrials.gg
TerminatedNCT00511758Updated Aug 1, 2012

Digital Imaging Aid for Assessment of Cervical Dysplasia

An observational study in Cervical Dysplasia, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-01.

Sponsored by M.D. Anderson Cancer Center · Observational

Why this study was terminated
Low accrual rate.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
3
Ages
18 Years and older
Sex
Female
01

Study 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.
Read the 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.

02

Conditions studied

  • Cervical Dysplasia

Keywords

  • Cervical Dysplasia
  • Digital Imaging
  • Colposcopy
  • Cervix
03

In context

Uterine Cervical Dysplasia

356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.

This study's enrollment of 3 is below the median of 470 across 96 observational studies indexed under Uterine Cervical Dysplasia.

Browse Uterine Cervical Dysplasia studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.

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

Exclusion Criteria:

  • Patients who are pregnant are not eligible for this study.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3 participants (actual)

Groups and cohorts

  • Digital Imaging Device

    Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.

    Procedure: Digital Imaging

Interventions

  • ProcedureDigital Imaging

    Images of the cervix will be taken using different types of light and compared with the colposcopy procedure.

06

What researchers measure

Primary outcomes

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

    Time frame: 2 Year

07

Study locations

1 site
  • U.T.M.D. Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00511758
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 6, 2007
Start date
Jun 2007
Primary completion
May 2009
Completion
May 2009
Last update
Aug 1, 2012

Study contacts

Michele Follen, MD, PhD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion