Reflectance Confocal Imaging in Cervical Cancer Patients

NCT00505726 | Completed DMC

• 2 other identifiers: ID01-555CA82880
• Study Type: observational
• Target: 39
• Locations: 2 countries
• Sites: 4

Brief Summary

The goal of this clinical research study is to see if reflectance confocal microscopy works as well as standard methods to detect cancer of the cervix or precancerous lesions. Primary Objectives:

1. 1.To identify potential clinical advantages for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using reflectance confocal microscopy.
2. 2.To obtain real time reflected light images in vivo of sites in the human cervix.
3. 3.To access the effects of acetic acid as a contrast agent for in vivo reflectance confocal imaging.
4. 4.Evaluate the depth of penetration for the fiber optic confocal device and analyze the diagnostic value of images taken from different depths.
5. 5.Determine the sensitivity and specificity of this device for the diagnosis of CIN.

Conditions

Cervical Cancer

Keywords

Cervical Intraepithelial Neoplasia; Cervical Cancer; Reflectance Confocal Imaging; Colposcopy

Outcome Measures

Primary Outcomes (1)

• Reflectance confocal images of cervical tissue in vivo

  1-2 minutes during routine colposcopy

Study Arms (1)

Confocal Microscopy

Procedure: Reflectance Confocal Imaging

Interventions

Reflectance Confocal Imaging PROCEDURE

Microscopic images taken during routine colposcopy where disinfected probe inserted into vagina and placed against cervix, 1-3 regions imaged (2 abnormal and one normal), and each taking about 1-2 minutes.

Confocal Microscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women, 18 years of age or older, who are already scheduled for colposcopy to detect or treat cervical lesions.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant individuals will be ineligible for this study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Lyndon B. Johnson Hospital

Houston, Texas, 77030, United States

Location

U. T. Health Science Center

Houston, Texas, 77030, United States

Location

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

British Columbia Cancer Research Center

Vancouver, British Columbia, Canada

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Study Officials

• Michele Follen, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 23, 2007
• Study Start: November 1, 2001
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

CA (1); US (3)