Doctors at El Camino Hospital broke new ground in the fight against cancer last month, debuting a new robot-guided procedure designed to find and diagnose one of the deadliest diseases in the United States.
Lung cancer claims the lives of more than 155,000 Americans annually, with a mortality rate exceeding those of prostate, colon and breast cancers combined. But the tools for detecting and diagnosing malignant tissue in the lungs are unreliable and difficult to use, depending on technology that hasn't changed much since the mid-20th century.
That could change soon. A clinical trial taking place at El Camino is ditching old bronchoscopy techniques in favor of an advanced robotic system called the Monarch Platform, which can guide a slender camera through the narrowest regions of the lungs and take tissue samples of suspicious "nodules" that could be malignant. The first procedure on a live patient -- and the first of its kind in the U.S. -- took place on March 30 without a hitch.
The device, created by the med-tech company Auris Health, marks a much-needed "paradigm shift" in the way physicians diagnose lung disease, said Dr. Ganesh Krishna, who performed the procedure last month. He said using a conventional bronchoscope is subject to human error, challenging to maneuver, and is too large to fit in the smallest branches of the lungs, which poses a serious challenge in diagnosing potentially cancerous nodules in the lungs.
"It can only go so far," Krishna said. "Periphery access has always been the Holy Grail."
Newer techniques relied on image-guided bronchoscopy using CT scans as a means for guiding the procedure, but a virtual layout of the lungs is hardly the same as peering directly into the lungs using a camera, he said.
The Monarch Platform is composed of two parts -- the robot-guided bronchoscopy tool itself and a cabinet holding a video feed from the camera and a controlling device used by the physician. The device's sleek white plastic frames and glowing blue LED lights stood out in the operating room inside El Camino's old main hospital building, appearing downright futuristic next to a dimly lit hallway full of older medical devices.
The frustrating reality is that old-school bronchoscopy techniques are often ineffective at reaching suspect lung tissue and retrieving conclusive biopsy results, which leaves many patients in suspense about whether or not they have cancer. A 2015 study published in the New England Journal of Medicine found that half of the 500,000 bronchoscopy exams done each year in the U.S. are for suspected lung cancer, of which 43 percent come back "nondiagnostic." In other words, more testing needed to be done to figure out if the patient has cancer, which could include more invasive procedures like transthoracic needle biopsies and surgical lung biopsies.
The study found that 35 percent of patients with benign lesions underwent invasive procedures following inconclusive results.
Having an early, accurate diagnosis is valuable to both the health and mental well-being of the patient, Krishna said. Patients who detect early stage lung cancer have upwards of a 60 percent chance to survive five years after diagnosis, but that number plummets to between 12 and 15 percent for stage 4 lung cancer. An estimated 90 percent of people with lung cancer die from the disease.
With so much emphasis on early detection -- and such a high rate of inconclusive results -- patients could be stuck doing a series of follow-up scans and procedures that could span from three months to two years, causing them huge levels of anxiety, Krishna said. A large majority of suspect lung nodules are not cancerous, but that's hardly enough to give patients peace of mind.
"Even though, statistically, 90 percent are not cancer, that's still going to interrupt your sleep," he said.
Auris Health, based in Redwood City, has been working on the new lung tech for the last six years, quietly amassing $500 million in funding and expanding to 200 employees, according to Eric Davidson, the company's VP of sales and marketing. He said he still calls Auris a startup venture, but it's clearly outgrown the designation.
The Monarch Platform is the company's first product to receive FDA clearance, and while it debuted in the U.S. for the first time in March, the company aims to make a country-wide launch after wrapping up the clinical trial at El Camino in the coming months.
Davidson said the company has sought to replace the standard bronchoscope, which he said is essentially a tube and a camera outfitted with a needle for biopsies. Aside from improvements in camera imaging, the technology really hasn't changed much over the last 70 years, he said, and there's a big unmet need to overcome the "technical and clinical limitations of the status quo."
"You're basically using a flexible tube that looks like a wet noodle and trying to navigate it in the lung," he said.
Instead of holding the bronchoscope and hand-feeding a fibre-optic tube into the patient, the Monarch Platform has the physician controlling the whole process using analog sticks on something that looks suspiciously familiar to an Xbox controller. That's because the earliest prototypes used by physicians, Davidson said, were literally equipped with Xbox controllers, and it worked so well that the design never really strayed far from the same ergonomic video-gaming design.
"We had a whole user-centric design process with 20 variations," Davidson said. "We kept coming back to a very similar design."
One of the buttons on the controller can essentially "park" the bronchoscope in one spot, stabilizing the device and making it significantly easier to do a biopsy. Krishna said being able to keep the bronchoscope steady is a huge deal in an organ that's constantly moving, adding much-needed precision to a procedure that can have serious health risks if the lung is inadvertently punctured.
Despite the high death toll, federal funding for cancer and other lung diseases has historically taken a backseat to other diseases. One 2006 study found that the "disease burden" of lung cancer, which includes death rates, years of life lost and years spent living with the disease, outstrips the amount of research funding the National Institute of Health provides each year -- a trend that hasn't shifted course since the 1990s.
Davidson said lung cancer and chronic obstructive pulmonary disease (COPD) are health problems that need to be addressed on a global scale, particularly in regions with poor air quality and high smoking rates. He said the hope is that the technology Auris is working on can make a big difference in regions like China, but so far the company has stuck to domestic testing grounds.
"Our first geography we're tempted to tackle is in the U.S., where lung cancer kills more than the next three cancers combined," he said.