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Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)

Phase 1
18 Years
Not Enrolling
Cervical Cancer

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Trial Information

Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)

Confocal microscopy may be a new way to detect lesions of the cervix quickly without
removing a tissue sample. Women in the study will already be scheduled for colposcopy to
detect or treat cervical lesions. (A colposcopy is an exam of the vagina and cervix using a
magnifying lens.)

Microscopic images will be taken during the routine colposcopy in the outpatient clinic. A
disinfected probe will be inserted into the vagina and placed against the cervix. . The
probe sends out laser light and detects reflected light from the tissue. Images of cervical
tissue will be formed and displayed on a computer monitor. 1-3 regions of the cervix will
be imaged (2 abnormal and one normal), and each will take about 1-2 minutes.

Each imaged site will be biopsied. The biopsies will be analyzed by the research
pathologist. The results will be available to participants in the event that care needs to
be given. Total participation in this study will be only a few minutes.

This is an investigational study. About 72 women will take part in this study. About 18
will be enrolled at M. D. Anderson.

Inclusion Criteria:

- Subjects will be individuals 18 years of age or older, who have voluntarily responded
to advertisement in the form of posted flyers or word of mouth.

- Subjects must sign an informed consent indicating awareness of the investigational
nature of this study.

Exclusion Criteria:

- Pregnant individuals will be ineligible for this study.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Reflectance confocal images of cervical tissue in vivo

Outcome Time Frame:

1-2 minutes during routine colposcopy

Safety Issue:


Principal Investigator

Michele Follen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2001

Completion Date:

September 2007

Related Keywords:

  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia
  • Cervical Cancer
  • Reflectance Confocal Imaging
  • Colposcopy
  • Uterine Cervical Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ



U.T.M.D. Anderson Cancer Center Houston, Texas  77030
Lyndon B. Johnson Hospital Houston, Texas  77030
U. T. Health Science Center Houston, Texas  77030