Mount Sinai Health System has launched a clinical trial of a new imaging device for detecting head and neck cancer during surgery.
The device, called Otis Wide Field OCT, by Perimeter Medical Imaging, is an ultra-high-resolution imaging system that can image tumor specimens in real time during surgery, allowing surgeons to remove all of the cancerous tissue during one procedure, rather than waiting for traditional pathology results to come in afterward, which can often lead to additional procedures.
Patients in the trial agree to have their tumors placed in the system for imaging, which is then compared to the standard pathology evaluation.
“State-of-the-art imaging platforms, such as the Otis system and others, will likely play a significant role in the future of head and neck cancer surgery. While traditional pathologic examination of tissues is the standard around the world, we need new technology to allow us to detect cancer and ensure adequate resection at the time of surgery,” explains lead investigator Brett Miles, associate professor of Otolaryngology at the Icahn School of Medicine at Mount Sinai, and co-chief of the Division of Head and Neck Oncology for the Mount Sinai Health System.
“Data from this study, and other projects in the optical imaging program, will help us understand how beneficial these technologies may be and drive future innovation during head and neck cancer surgery,” Miles said in a statement.
Men’s risk of contracting these cancers is twice as high as women’s. Tobacco use and excessive drinking are major contributors, especially for male patients over the age of 50. However, cancers of the oropharynx are dramatically increasing among younger men who don’t smoke, because of the human papillomavirus.
The U.S. Centers for Disease Control and Prevention estimates that more than 16,000 HPV-associated oropharyngeal cancers are diagnosed yearly in the United States, while The American Cancer Society says 7% of adult Americans have oral HPV. Men are four times more likely to develop these cancers than women, and this ratio may nearly double by 2030.
“Although no screening test currently exists for early detection of HPV-related oropharyngeal cancers, it is critically important to recognize symptoms of the disease. Any patient with persistent throat pain or a lump in the neck needs to be evaluated by a physician,” Raymond Chai, assistant professor of Otolaryngology at the Icahn School of Medicine at Mount Sinai, and director of Head and Neck Robotic Surgery at Mount Sinai Downtown said.
“The FDA has recently approved the expansion of Gardasil 9, the HPV vaccine, for use in patients from the ages of 27 to 45. The vaccine has been previously demonstrated to prevent over 90% of possible HPV-related cancers,” Chai said in a statement.
Investigators from the Head and Neck Cancer Research Program at the Icahn School of Medicine at Mount Sinai are also conducting a high-risk HPV screening study, along with colleagues from Johns Hopkins University and three other institutions.
The study, known as MOUTH, is a clinical trial to better understand how risk factors affect oral HPV infection rates. In this study, researchers are collecting samples of blood, saliva, and urine to test them for HPV antibodies.
So far, approximately 630 samples have been collected, and patients who screened positive for high-risk HPV viral types are entering the close observational arm of the study, in which they will receive clinical visits and imaging, such as ultrasound and MRI, to monitor them for head and neck cancer. They will be monitored annually for the next five years. The study is currently open and enrolling patients.
