Clinical Trial Begins for New Cervical Cancer Detection Optical Probe
M. D. Anderson News Release 03/01/00
HOUSTON - A new cervical cancer detection method, which uses a small fiber optic probe instead of a surgical knife, is being tested through an $11 million National Institutes of Health grant for clinical trials at The University of Texas M. D. Anderson Cancer Center in Houston.
The trials employ a cancer-detecting optical probe developed by electrical engineering professor Dr. Rebecca Richards-Kortum at The University of Texas at Austin. Dr. Michele Follen, a professor of gynecologic oncology at M. D. Anderson, is leading the clinical trial to support U.S. Food and Drug Administration approval of the device.
Dr. Richards-Kortum's painless probe is being used on 1,800 women in three Houston locations as an alternative to the colposcopy - the test which is a followup to the long-standing, painless cancer detection procedure known as the Pap smear. Colposcopy is performed after the Pap smear indicates the possibility of cervical cancer - the second most common cancer in women worldwide. A smaller trial will also take place in British Columbia, Canada, where Dr. Calum MacAulay of the British Columbia Cancer Centre is assessing the device's technical feasibility.
If the new probe imaging method proves effective and cost efficient, it could replace the Pap smear as a front-line detection tool, according to researchers. Pap 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.
Dr. Richards-Kortum's probe employs fluorescence and reflectance spectroscopy - measuring the wavelengths of light bounced off different surfaces. The probe shines light on the cervix and reports what it sees to a computer in the physician's office. Because cancer cells interact with light differently than healthy cells, the computer translates the light's interaction into either a healthy report or a possible problem.
"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 percent."
Immediate results are more readily available to patients with no need for invasive biopsies and two-week follow-up appointments typically required to confirm the presence of pre-cancerous cells with standard screening methods.
Dr. Scott Cantor, assistant professor in M. D. Anderson's new Department of Health Services Research, will study the societal benefits of the device, such as reduced costs and fewer visits to the doctor's office. Meanwhile, Dr. Karen Basen-Engquist, assistant professor of behavioral science at M. D. Anderson, will measure patient satisfaction with the device and other patient outcomes.
In other parts of the multi-faceted project, Dr. Dennis Cox of Rice University in Houston will collaborate with Dr. E. Neely Atkinson of M. D. Anderson to compile statistics in the studies, and Dr. Anais Malpica of M. D. Anderson working with Dr. Neil Poulin of British Columbia will head up pathological studies. The collaborative approach to this translational research project helped secure its funding, according to Dr. Follen.
Dr. Richards-Kortum, who has developed the optical system over the past 10 years with Dr. Follen, estimated this technology could save up to $625 million annually in the United States through more efficient and effective cervical screenings. Dr. Urs Utzinger, also at UT Austin, will work on fine-tuning the instrumentation during the course of the 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.
Dr. Follen agreed, saying, "The treatment of cervical cancer could be vastly improved by technologies which increase accuracy, automate results, and decrease the costs of screening and detection."
Two years ago Dr. Richards-Kortum licensed the optical technology to Lifespex, a small company which is conducting human trials in Europe. If these studies prove successful, she plans to point her laser at other potential cancers. "The technology could have broad applications to other organ sites such as the oral cavity, lungs, the digestive tract, the bladder and skin," Dr. Richards-Kortum predicts.
Women ages 18 and over with either normal or abnormal Pap smears who are interested in participating in the clinical trial should call (713) 745-2351.
About UT's College of Engineering: The University of Texas College of Engineering ranks among the top ten public engineering schools in the United States. With the nation's third highest percentage of faculty elected members of the National Academy of Engineering, the College's 6,000 students gain exposure to the nation's finest engineering practitioners. Appropriately, the College's logo, an embellished checkmark used by the first UT engineering dean to denote high quality student work, is the nation's oldest quality symbol. The College maintains a web site at http://www.engr.utexas.edu/.
About M. D. Anderson: The University of Texas M. D. Anderson Cancer Center in Houston ranks as one of the world's most respected centers devoted exclusively to cancer patient care, research, education and prevention. M. D. Anderson is one of only 36 cancer centers in the nation designated by the National Cancer Institute as a Comprehensive Cancer Center. For 10 consecutive years, U.S. News & World Report's "Best Hospitals" issue has ranked M. D. Anderson one of the two best cancer centers in the nation. The institution's web page is at www.mdanderson.org.