One of the many challenges in gynecology is dealing with pelvic findings that are unclear such as ovarian cysts and pelvic masses, which are quite common among women. To diagnose whether the tumor is malignant or benign, numerous indirect tests must be performed, including a physical exam, imaging tests (CT, ultrasound, MRI), blood tests, statistical evaluation and more. There are cases in which surgery is performed and a specimen of the finding is taken for more in-depth diagnosis.
In recent years, Hillel Yaffe has been conducting a unique study designed to provide an advanced technological solution for diagnosis of pelvic findings. The study has been led by the Director of the Gynecology Department and Gynecologic Oncology at Hillel Yaffe, Prof. Ilan Bruchim, in conjunction with the Gynecologic Oncology Unit, the Gynecology Department's Research Laboratory, Hillel Yaffe’s Pathology Institute and researchers Dr. Dov Malonek and Dr. Ben Zion Dekel from Ruppin Academic Center. As part of the project, the participants searched for advanced technology that would allow them to achieve an accurate, accessible and faster assessment - even during actual surgery and, by doing so, to improve and streamline intraoperative decision-making.
As previously mentioned, there are currently two standard surgical methods: one, investigational surgery (generally using a minimally invasive laparoscopic approach), during which they remove the suspicious finding, send it for comprehensive pathology testing, and 10-14 days later a final answer is received about whether the finding is malignant or benign. This test is considered the gold standard and has the highest diagnostic value. “If we are dealing with a malignant finding, the patient will come back for additional, extensive surgery in which the related organs will be removed, as required and depending on the type of tumor,” said Prof. Bruchim and Dr. Tomer Bar-Noy, senior physician in the Gynecologic Oncology Unit in the Gynecology and Obstetrics Division at Hillel Yaffe Medical Center.
The disadvantages of this method are the need for additional surgery and the sense of uncertainty and time required to wait for the diagnostic answer. The second method is a single surgery, with an assessment of the findings during the actual surgery. “With this method, diagnostic surgery is performed, during which the suspicious finding is removed and sent for direct pathological assessment during surgery itself.” This method is called frozen section. “According to the answer received, we decide on how to continue surgery. The advantage is that additional surgery is unnecessary. However, the disadvantages are the need for a special and available pathology team; it takes approximately 45 minutes for the pathology diagnosis to be received and accuracy is only 80%,” noted Dr. Bar Noy.
Prof. Bruchim and the innovative device at the Hillel Yaffe Medical Center
In the innovative study conducted by Hillel Yaffe and Ruppin Academic Center, technology was developed to enable a specimen from the tumor removed during surgery to be examined using a special device. An answer as to whether the tumor is benign or malignant is received within approximately five minutes. “The device developed is based on electro-optics technology which measures the spectral signature of the suspicious finding. Machine learning techniques provide the device with the ability to classify the suspicious specimen as malignant or benign,” said researchers Dr. Malonek and Dr. Dekel.
In an initial experiment, the results of which were published, specimens were taken in 27 gynecological surgeries, on which analysis was performed along with a comparison against the final pathological results, in order to examine the detection ability and accuracy of the device. “We found that the reliability of the technology developed is very high, at 94%,” said Prof. Bruchim.
“The innovative method provides an outstanding response to the disadvantages typical of the standard methods. The diagnosis and treatment are provided in a single surgery, quickly (within several minutes), with no need for a pathologist and with a very high level of accuracy. It is a quick and feasible solution, as the test can be performed anywhere and anytime. The next step in the study is to examine whether the system will allow us to also diagnose the type of tumor and stages of malignancy, as is done in the comprehensive pathology test, and to examine implementation of the technology in different tumors and surgeries, in fertility treatment and more,” said the researchers from Hillel Yaffe and Ruppin Academic Center.