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A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of the Normal Cervix for Screening, Using a Second Generation Device

Phase 1
18 Years
Not Enrolling
Cervical Neoplasia

Thank you

Trial Information

A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of the Normal Cervix for Screening, Using a Second Generation Device

A colposcopy is an exam of the vagina and cervix using a magnifying lens. A multi-spectral
digital colposcopy uses a digital camera and a special light to take pictures of the cervix
and vagina.

Before taking part in this study, you will have a complete medical history recorded. You
will have a physical exam and a pap smear. Women who are able to have children must have a
negative urine pregnancy test.

You will then have a multi-spectral digital colposcopy performed during the routine
colposcopy in the outpatient clinic. A multi-spectral digital colposcopy device will shine
light on the cervix and vagina and take several pictures. The pictures will be used by the
doctors to check the cells and structure of the tissue. After the first set of pictures,
acetic acid (vinegar) will be applied to the cervix so any lesions would show up better.
Application of acetic acid is a normal part of the colposcopy and not part of the research.
About 1-2 minutes later, more pictures will be taken.

If the acetic acid/colposcopy show abnormal cells, you will have a biopsy of the cervical

If the acetic acid /colposcopy show normal cells, no biopsy will be taken.

Once you have completed the colposcopy with or without the biopsy of the cervical canal,
your participation on this study is complete.

If either your Pap smear or biopsy of the cervical canal is abnormal, the study doctor/staff
will recommend further care or treatment.

Inclusion Criteria:

1. Women 18 years of age or older.

2. Women who have been referred for screening at U.T.M.D. Anderson Hospital, Houston, TX
USA; U.T. Health Science Center-Houston,TX USA; Lyndon B. Johnson General Hospital,
Houston, TX USA; British Columbia Cancer Agency, Vancouver, British Columbia, Canada;
and the University College Hospital, Ibadan, Oyo State, Nigeria, Africa Cervical
Screening Clinics, Family Planning Clinics or Gynecology Clinics.

3. Patients must sign an informed consent indicating awareness of the investigational
nature of the study.

Exclusion Criteria:

1. Patients will be considered ineligible if they are pregnant.

2. If they have a history of an abnormal Pap or a treatment to the cervix.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Multi-spectral Digital Colposcopy

Outcome Time Frame:

Extra 2 minutes to image during routine colposcopy procedure

Safety Issue:


Principal Investigator

Andrea Milbourne, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

February 2009

Related Keywords:

  • Cervical Neoplasia
  • Cervix
  • Cervical dysplasia
  • Cervical neoplasia
  • Cervical intraepithelial neoplasia
  • Multi-spectral Digital Colposcopy
  • MDC
  • Acetic acid
  • Colposcopy
  • Spectroscopy
  • Fluorescence Spectroscopy
  • Abnormal Pap Smear
  • Neoplasms



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