Rationale and objective: Ovarian cancer, the most deadly female reproductive cancer, has a high death rate because there are very few symptoms in the early stages of the disease. Most cases are diagnosed at stages when the disease has spread, making it more difficult to treat or cure. Since the cancer is so deadly, and no effective screening method currently exists, women at high risk may elect to undergo prophylactic removal of their ovaries. However, the ovaries provide health benefits even in post-menopausal women, and removal of the ovaries can increase mortality in women under 45.

The objective of this research is to perform a first clinical pilot test of a miniature viewing device, called a falloposcope, which can be used to visualize the ovaries without requiring general anesthesia or cutting of tissue. The falloposcope will contain fiber optics to deliver light to the tissue and collect reflectance and fluorescence, using two techniques called multispectral fluorescence imaging (MFI) and optical coherence tomography (OCT). We have built a laboratory prototype of the falloposcope and have shown in ex-vivo biopsies that MFI and OCT can distinguish between normal, cancer, and benign abnormality tissues.

Central problem addressed: The central problem addressed is the lack of an ovarian cancer screening method. The next step in translation of our prototype falloposcope is to perform a feasibility and safety study in women. We have chosen to perform this first clinical study in women undergoing removal of the lining of the uterus and their fallopian tubes because of excessive bleeding. Testing the falloposcope is low risk in this group because they are already having a larger scope inserted in their uterus, and their tubes are being removed anyway. We will have a chance to prove that our falloposcope can be inserted and take pictures of the fallopian tubes, and prove that it does not cause damage. We also need to understand what "normal" fallopian tubes look like, and how much variation there is. After this proposed study we will be poised to perform the larger, more difficult study in high-risk women to assess efficacy -- the likelihood of success in finding cancer.

Who/How will it help? The initial target group is women at elevated risk for ovarian cancer (family or personal history of breast or ovarian cancer, certain gene mutations). These women might be counseled to undergo prophylactic removal of the ovaries, but, as mentioned above, this procedure can have negative health consequences as well as the loss of fertility. Eventually, we hope to show that screening with our falloposcope is safe and effective enough to be used as a regular screening procedure for all women, such as is done now for mammography (breast cancer) or Pap smear (cervical cancer).

Clinical applications/benefits/risks: The falloposcope will be introduced through the vagina to the uterus and pass through the fallopian tubes to the ovary. The procedure is similar to a colonoscopy in that it requires local but not general anesthesia, and no tissue cutting is required. The desired benefits are that ovarian cancer could be caught early, when it is treatable, and that women at high risk might be able to delay or avoid having their ovaries removed. Also, because this endoscope images both the fallopian tubes and ovary, it will screen for two types of cancer. Current research suggests that aggressive ovarian cancers actually start in the fallopian tubes. The risks are that patients might react to the anesthesia, that the falloposcope might damage or perforate the reproductive tissue, that the falloposcope might not be sensitive enough to detect a cancer, or that the falloposcope might falsely indicate that a benign condition is cancer, leading to unnecessary further tests or removal of the ovaries. Our current study is designed to examine the risk of damage, and future studies will assess the risk of false results.

Impact on health/welfare of Service members/families/other beneficiaries: Ovarian cancer is a devastating disease that claims too many lives, affecting families and loved ones as well as the victim. Current risk-reducing methods can severely impact quality of life. We expect that a screening method based on falloposcopy can save lives and improve quality of life for all women, including Service members.