Mount Sinai Launches Clinical Trial of New Imaging Device for Head and Neck Cancer Surgeries
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, DDS, MD, 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.”
Oral and head and neck cancers are among the most rapidly increasing forms of cancer in the United States, especially among a younger population. They occur in the tongue, tonsils, and throat, as well as the nasal cavity, sinuses, lips, mouth, thyroid, and salivary glands. According to the Head and Neck Cancer Alliance, in 2019 more than 550,000 new cases will be diagnosed and approximately 300,000 people will die from these cancers worldwide. The American Cancer Society projects 53,000 cases will be diagnosed in the United States this year, and an estimated 10,860 people will die of these cancers.
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 (tonsil and base of tongue) are dramatically increasing among younger men who don’t smoke, because of the human papillomavirus (HPV). 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 percent 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,” says Raymond Chai, MD, 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. “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 percent of possible HPV-related cancers.”
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.
“We are pleased to be participating in this groundbreaking study, and glad that patients are willing to participate in this work. Currently there exists no accepted screening method for HPV-related head and neck cancer, despite the fact that there are currently more cases diagnosed in the United States than cases of cervical cancer [which is also caused by HPV]. It’s truly an epidemic. In many cases the cancer is asymptomatic for significant periods of time, making the discovery of new detection methods vital. This study provides important information on who is at risk, and who needs additional follow-up for high-risk HPV infection in the head and neck,” explains Dr. Miles.
For more details please visit:
http://icahn.mssm.edu/mouthstudy
https://icahn.mssm.edu/research/head-neck-cancer/optical-imaging
Facts About Oral, Head, and Neck Cancer:
- Smokers generally develop head and neck cancer in their 60s.
- Men are twice as likely to be affected because of smoking patterns and HPV risks.
- For HPV-related throat cancer, non-smoking men ages 35 to 55 are at highest risk, although doctors are starting to see more cases in women.
- Initial symptoms of oral, head, and neck cancer include a sore in the mouth that doesn’t heal, sore throat, trouble swallowing, lumps or patches in the mouth, changes in voice, and a lump in the neck.
- 50 percent of people with head and neck cancers have very advanced cases by the time they first see a doctor.
- A lump in the neck that does not go away may be a head and neck cancer, even without other symptoms such as pain.
Tips for Prevention:
- Don’t smoke or use other tobacco products.
- Don’t drink alcohol frequently or heavily or combine with tobacco use.
- Limit sun exposure and regularly use sunscreen, including lip balm with a strong SPF.
- Reduce your risk of HPV infection by limiting the number of sexual partners—having many partners increases the risk of HPV infection. Using a condom cannot fully protect you from HPV during sex.
- Maintain proper care of dentures. Poorly fitting dentures can trap cancer-causing substances in tobacco and alcohol. Denture wearers should have their dentures evaluated by a dentist at least every five years to ensure a good fit. Dentures should be removed every night and cleaned and rinsed thoroughly every day.
About the Mount Sinai Health System
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with 48,000 employees working across seven hospitals, more than 400 outpatient practices, more than 600 research and clinical labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time—discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 9,000 primary and specialty care physicians and 11 free-standing joint-venture centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida. Hospitals within the System are consistently ranked by Newsweek’s® “The World’s Best Smart Hospitals, Best in State Hospitals, World Best Hospitals and Best Specialty Hospitals” and by U.S. News & World Report's® “Best Hospitals” and “Best Children’s Hospitals.” The Mount Sinai Hospital is on the U.S. News & World Report® “Best Hospitals” Honor Roll for 2024-2025.
For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Instagram, LinkedIn, X, and YouTube.