Mount Sinai Launches Clinical Trial of New Imaging Device for Head and Neck Cancer Surgeries


Doctors promote prevention during Oral and Head and Neck Cancer Awareness Month  

Newswise — (New York, NY- April 15, 2019)- 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.

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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

The Mount Sinai Health System is New York City's largest integrated delivery system encompassing (with the addition of South Nassau Communities Hospital) eight hospital campuses, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai's vision is to produce the safest care, the highest quality, the highest satisfaction, the best access and the best value of any health system in the nation. The Health System includes approximately 7,480 primary and specialty care physicians; 11 joint-venture ambulatory surgery centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools", aligned with a U.S. News & World Report's "Honor Roll" Hospital, No. 12 in the nation for National Institutes of Health funding, and among the top 10 most innovative research institutions as ranked by the journal Nature in its Nature Innovation Index. This reflects a special level of excellence in education, clinical practice, and research. The Mount Sinai Hospital is ranked No. 18 on U.S. News & World Report's "Honor Roll" of top U.S. hospitals; it is one of the nation's top 20 hospitals in Cardiology/Heart Surgery, Gastroenterology/GI Surgery, Geriatrics, Nephrology, and Neurology/Neurosurgery, and in the top 50 in six other specialties in the 2018-2019 "Best Hospitals" issue. Mount Sinai's Kravis Children's Hospital also is ranked nationally in five out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 11th nationally for Ophthalmology and 44th for Ear, Nose, and Throat. Mount Sinai Beth Israel, Mount Sinai St. Luke's, Mount Sinai West, and South Nassau Communities Hospital are ranked regionally.

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