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Clinical Trial Begins for New Cervical Cancer Detection Optical Probe
(Last Updated: 05/11/05)

Optical ProbeA new cervical cancer detection method, which uses a small fiber optic probe instead of a surgical knife, is being thoroughly tested through an $11 million Program Project re-funded by the National Institutes of Health/National Cancer Institute at The University of Texas M. D. Anderson Cancer Center in Houston.  The trials employ a cancer-detecting optical probe developed by Dr. Rebecca Richards-Kortum, professor of Biomedical Engineering at The University of Texas at Austin, and Dr. Michele Follen, a professor of gynecologic oncology at M. D. Anderson.

CervixThe probe will be tested on 1,800 women in five locations as an alternative to colposcopy, the test that is a follow-up to the long-standing, painless cancer detection procedure known as the abnormal Pap smear. A colposcopy is performed after the Pap smear indicates the possibility of cervical cancer, the second most common cancer in women worldwide. Early detection of cervical cancer and pre-cancers could significantly lower the mortality rate worldwide.  The trial is also taking place in British Columbia, Canada, where Dr. Calum MacAulay and Dr. J. Louis Benedet of the British Columbia Cancer Research Centre are assessing the device's technical feasibility.

According to researchers, if the new probe imaging method proves effective and cost-efficient, it could replace the Pap smear as a front-line detection tool.

ResearchersPap smears are obtained by collecting a sample of cells from the cervix with a wooden or plastic spatula and brush. Specimens are placed on glass slides and examined. If abnormalities are found, women are typically asked to return for colposcopy. A colposcope uses a magnifying lens to view the cervix under white and green light after a mild acid solution is applied. If trouble spots are seen, a biopsy is performed.

The probe employs fluorescence and reflectance spectroscopy - measuring the wavelengths of light bounced off of different surfaces. It shines light on the cervix and reports findings to a computer in the physician's office. Because cancer cells interact with light differently than healthy cells, the computer translates a “real-time” assessment of the light's interaction into either a healthy report or a potential problem.  Statisticians, E. Neely Atkinson and Dennis Cox are helping to develop innovative algorithmic approaches for the analysis of the data for these studies.

Researchers"The new device doesn't require as much training and visual recognition skills as required for performing a colposcopy," said Dr. Follen. "It narrows the reporting time and is estimated to reduce the false positive rate by 40%."  Immediate results are more readily available to patients with no need for unnecessary, invasive biopsies and two-week follow-up appointments typically required to confirm the presence of pre-cancerous cells with standard screening methods.

Preliminary results reported by Dr. Karen Basen-Engquist show that patients, in both the screening and diagnostic setting, find the probe less painful than other diagnostic procedures.

Dr. Richards-Kortum has developed the optical system collaboratively with Dr. Follen over the past 12 years.  Dr. Scott Cantor estimated this technology could save up to $625 million annually in the United States through more efficient and effective cervical screenings. Nick MacKinnon of the British Columbia Cancer Research Centre continues to work on fine-tuning the instrumentation during the course of trials. 

"In the United States alone, more than $6 billion is spent every year in the evaluation and treatment of low-grade precursor lesions, and resources are wasted on the evaluation and treatment of lesions not likely to progress to cancer," Dr. Richards-Kortum said.  A team of pathology researchers, including Drs. Anais Malpica, Gregg Staerkel, Jasenka Matistik, Dirk Van Neikerk, Karen Adler-Storthz and Martial Guillaud, have also addressed HPV tests, automated pap smear tests and quantitative biopsy readings.

Dr. FollenDrs. Guillermo Tortolero-Luna and Michele Follen, co-directors of the administrative core, are excited about the cultural diversity of the study, which includes Native American, Asian, Caucasian, Canadian, American, African-American, and Hispanic women.  Dr. Tortolero-Luna feels this will help to generalize the study.  Dr. Follen said, "The treatment of cervical cancer could be vastly improved by technologies which increase accuracy, automate results, and decrease the costs of screening and detection."

These trials are currently being conducted at:

The University of Texas M. D. Anderson Cancer Center
1515 Holcombe Blvd.
Houston, TX 77030

Lyndon B. Johnson General Hospital
5656 Kelley
Houston, TX 77026
USA

British Columbia Cancer Agency
600 W. 10th Ave.
Vancouver, BC Canada  V5Z 4E6

Women, ages 18 and over, with a history of normal Pap smears interested in participating in the clinical trial, should call (713) 745-4983. At this time, patients that have ever had an abnormal Pap smear result do not quality. 

For more information about the cervical probe study and/or to register, you may contact us by dialing:

  • The University of Texas M. D. Anderson Information Line at (800) 392-1611
  • By dialing directly to (713) 745-4983
  • Download the research opportunity flyer
   

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1515 Holcombe Blvd, Houston, TX 77030
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