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NCT00513123 Clinical Trial

Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

Cervical Cancer Clinical Trial

Official title:
A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00513123
Other study ID # GYN98-258
Secondary ID
Status Completed
Phase N/A
First received August 7, 2007
Last updated July 31, 2012
Start date September 2002
Est. completion date February 2009

Study information
Verified date July 2012
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using digital colposcopy for colposcopy for fluorescence spectroscopy.

Other Objectives:

- To measure digital fluorescence and reflectance images in vivo of sites in the human cervix.

- To evaluate the effect of acetic acid in the image contrast obtained.

- Compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy.

Description:

DCF may provide a better way to detect or treat lesions of the cervix. Women in the study will already be scheduled for colposcopy to detect or treat lesions of the cervix. (A colposcopy is an exam of the vagina and cervix using a magnifying lens).

DCF will be done during the routine colposcopy in the outpatient clinic. A digital colposcope (DC) device will be used to take a sequence of images of the cervix and vagina. (A DC is a digital camera connected to the colposcope with a specialized light source. It will shine light on the cervix and acquire a sequence images). The images will tell doctors about the cells and structure of the tissue. After the first set of images, acetic acid will be applied to the cervix so that lesions show up better, and 1-2 minutes later more readings will be taken.

Small samples of areas of abnormal tissue will be removed during colposcopy. Taking these tissue samples is a routine part of this type of exam. If patients are having colposcopy and loop electrosurgical excision procedure (LEEP treatment, one sample of normal tissue will be taken. (The cervix will be numbed for this procedure.) DCF images will be compared with lab findings from these samples. Before DCF is done, as standard of care, patients will have a complete history and physical exam, urine pregnancy test, pap smear, and cultures for gonorrhea, chlamydia and viral testing.

This is an investigational study. About 114 women will take part in this study. About 22 will be enrolled at M. D. Anderson.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women 18 and older with an abnormal Pap

Exclusion Criteria:

- Pregnant individuals will be excluded from this study

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Colposcopy
As part of routine colposcopic evaluation, patients will undergo routine colposcopy with the digital colposcope (DC) will then be used to take an image of the vagina and cervix.

Locations
Country Name City State
Canada British Columbia Cancer Research Center Vancouver British Columbia
Nigeria University College Hospital Ibadan Oyo State
United States Lyndon B. Johnson Hospital Houston Texas
United States U.T. Health Science Center Houston Texas
United States U.T.M.D. Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Nigeria, 

Outcome
Type Measure Description Time frame Safety issue
Primary To study whether digital colposcopy for fluorescence (DCF) can perform better than standard methods to detect cancer of the cervix or precancerous lesions. 7 Years No
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