Spectroscopic Evaluation of Cervical Neoplasia

Completed

Conditions studied: Cervical Neoplasia

In brief

The overall objective of this study is to evaluate whether fluorescence and reflectance spectroscopy can improve the ability to detect the presence of premalignant lesions on the cervix. The specific aims of the study are: * To compare information obtained from fluorescence and reflectance spectroscopic measurements of the cervix with standard methods for detecting cervical pre-cancers. * To validate previously developed algorithms for discriminating between normal and pre-cancerous tissue based on spectroscopic measurements. * To evaluate the safety of spectroscopic measurement of cervical tissue.

Key facts

Study ID

NCT00766701

Run by

Guided Therapeutics

People needed

1599

Starts

2003-01-01

Expected to finish

2008-09-01

Last updated by the study team

2008-10-06

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age 16 or above
• Able to read or understand and give informed consent
• Scheduled for colposcopy
• Pap test within 120 days
• Willing to undergo a Pap test and HPV test on day of study

You may not qualify if…

• Pregnancy
• Menstruating on the day of colposcopy and CNDS test
• Radiation therapy to her genitourinary system within 1 year
• Prior hysterectomy
• Congenital anatomical cervical variant (e.g., double cervix)
• Friable cervix at the time of the study (i.e., a cervix that bleeds easily upon minimal contact or trauma)
• Post-coital or other significant bleeding at the time of the exam
• Excessive cervical mucous or discharge that cannot be removed and is significant enough, in the opinion of the investigator, to interfere with a Pap test or colposcopy, resulting from inflammatory, bacterial or other sources
• History of any photosensitizing disease or other disease affected by Ultra-violet radiation, (e.g., pophyria, Lupus Erythematosus).
• Undergoing phototherapy
• Recent use of photosensitizing agents, such as fluoroquinolones or retinoids).
• Patients who are pregnant are not eligible for this study.

Where it is running

• University of Arkansas — Little Rock, Arkansas, United States
• Orange Coast/Saddleback — Laguna Beach, California, United States
• Saint Francis Hospital — Hartford, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• University of Texas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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