The Food and Drug Administration recently approved the LUMA Cervical Imaging System for use in combination with routine cervical exams to detect precancerous disease. University of Iowa Hospitals and Clinics is one of five centers that will install LUMA as part of a nationwide clinical study to determine the effectiveness of the system coupled with existing methods.
Colleen Kennedy, MD, gynecologist at University of Iowa Hospitals and Clinics. Talks about the LUMA system’s use in detection of cervical cancer:
How many women develop cervical cancer?
In the United States, about 11,000 women per year develop cervical cancer.
Are there signs or symptoms of cervical cancer?
Unfortunately the signs and symptoms of cervical cancer tend to be late in that you have bleeding either after intercourse between your periods. There are no early signs or symptoms of cervical cancer.
Currently, how are abnormalities or precancerous cells of the cervix detected?
The precancer cells are detected with screening and that is a Pap smear which was developed by Dr. George Papanicolaou in the early 1940s. This has not changed over the last 60 to 70 years. Women have cervical cancer screenings when they present for an annual examination.
How is that process different in the LUMA system?
With LUMA, it is used to enhance the follow-up testing after you’ve had an abnormal Pap smear. If you have an abnormal Pap smear, you are possibly referred for further evaluation of the cervix and that is done with colposcopy. Colposcopy is the instrument used to magnify the cervix so that you can look at it more closely. If there are any areas that appear abnormal, a biopsy would be performed to confirm the abnormality.
LUMA is a device that uses broad-spectrum and UV light to detect the abnormal areas in a more consistent and scientific manner. LUMA is used in conjunction with colposcopy to look at the cervix using this enhanced technique, and if there area abnormal areas, you have the biopsy performed to confirm the abnormality. Your initial screening is the Pap smear and that does not change. What changes is LUMA is used with colposcopy after an abnormal Pap smear to further evaluate the cervix.
Which women will qualify to be part of the study to detect cervical cancers?
As you noted, the LUMA is an FDA-approved device. It was approved in March 2006. This is a post-marketing study to further evaluate how effective LUMA is in conjunction with colposcopy. Any woman referred for colposcopy following an abnormal Pap smear would be eligible to be part of the study. Of course the woman needs to have a cervix.
What will participants be asked to do as part of the study?
If they are interested in enrolling in the study, they will have the LUMA performed in conjunction with colposcopy. They would still come in for their routine colposcopy, then for follow-up of the abnormal Pap smear, they would still undergo colposcopy just as always and the LUMA would be performed in addition to colposcopy. The LUMA itself takes just a couple of minutes. The machine does not touch the woman and there are no additional steps basically with the addition of LUMA to the colposcopy.
If a woman has a family history of cervical cancer and would like to be part of this study, what should she do?
Great question. This does not replace the Pap smear. If a woman has a concern about cervical cancer, she should undergo Pap smear screening every one to three years as recommended, depending upon her background risk factors. Only if the Pap smear is abnormal, should she have colposcopy as a possible follow-up and if colposcopy is indicated, she could add the LUMA as well.
Since the LUMA system is still in the research stage, will the women who participate in the study need to pay for the service? How is the study financed?
Tthis is FDA-approved and we’re using it a post-marketing evaluation to further define how effective it is in conjunction with colposcopy. We’re quite fortunate at The University of Iowa that we have a donation from John Pappajohn to evaluate cancer screening methods. He has donated money and the device for use here. Women who present then and have LUMA performed in conjunction with a colposcopy will not pay a fee for the LUMA service. They will still need to have coverage for the colposcopy and any biopsies that are performed. There will be no charge for addition of the LUMA whether or not they’re in the study.
How long will this research study last?
We think it is going to be about two years, but there are possibilities that they would want to evaluate it on a more long-term basis. So we’re looking at this point for the next two years at least.
What is the desired outcome of the study?
LUMA has been FDA-approved as an adjunct to colposcopy to detect cervical cancer and high grade cervical precancerous disease. The purpose of the post-marketing study is to see if there’s any population of women that are better served by the use of LUMA or if there is any benefit to LUMA based on the colposcopes skills and performance. And also to see if it matters whether or not women are HPV-positive with LUMA for the detection of cervical cancer and precancer. |
