• About the Clinical Trial
• Staff
• Eligiblity
• Contact

About the Clinical Trial

Cervical cancer is the 2nd most common cancer in women world-wide. A new cervical cancer detection method, which uses a small fibre optic wand instead of a surgical instrument, is currently undergoing testing. The study is being funded through an $11 million National Institutes of Health grant for clinical trials at BC Cancer Agency in Vancouver, BC (Vancouver General Hospital site). The trial employs a cancer-detecting optical wand developed by bioengineering professor Dr. Rebecca Richards-Kortum University of Texas at Austin and Mr. Nick MacKinnon and Dr. Calum MacAulay at the BCCA, in collaboration with Dr. Michele Follen, a professor of Gynecological Oncology at M.D. Anderson in Houston, Texas. Co-investigators Dr. J.L. Benedet, Dr. M Bertrand, Dr. D. Miller and Dr. T. Ehlen will be working on this clinical trial in Vancouver¸ B.C. at the Vancouver General Hospital Colposcopy Clinic. The wand is being used on 1800 women in five locations as an alternative to the colposcopy. The colposcopy is a follow-up to the long-standing, cancer detection procedure known as the Pap Smear.

If the new wand 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 vinegar solution is applied. If trouble spots are seen, a biopsy is performed.

The optical wand employs fluorescence and reflectance spectroscopy. It shines light on the cervix and reports what it sees to a computer in the examining room. 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.”

The new optical device, unlike standard screening methods, plans to offer immediate results to patients. There would be no need for invasive biopsies or the two week follow-up appointments that are typically required to confirm the presence of pre-cancerous cells.

BC Cancer Agency is looking for women willing to participate in this clinical trial

As part of the study, each participant will receive a health history, colposcopy, Pap Smear, cultures and fluorescence measurements of the cervix. A physical exam may be done as well. Cervical biopsies, and blood to determine hormone levels, will also be taken.

Staff

• Dr Lou Benedet, Principal Investigator
• Dr Monique Bertrand, Co-Investigator
• Dr Tom Ehlen, Co-Investigator
• Dr Dianne Miller, Co-Investigator
• Nick MacKinnon, Instrumentation Director
• Vibeke Sawyer, Project Coordinator
• Linh Cajigas, Behavioural Research Assistant
• Sylvia Au, Research Assistant
• Joyce Gabriel, RN
• Susan Keast, RN

Eligiblity

Must be 19 years of age or older, not pregnant, must have a cervix (no hysterectomy), and must have a history of normal pap smears. We are screening both pre-menopausal and post-menopausal women. Research is at no charge to participant.

The trial is currently being conducted at:

The Colposcopy Clinic Willow Pavilion
Vancouver General Hospital

Similar trials are available in Houston, Texas at four hospitals, including the M.D. Anderson Cancer Centre.

Contact

For more information about the Cervical Optical Wand Study, please contact the: