D. Kyle Hogarth, MD, FCCP, Associate Professor of Medicine, Director of Bronchoscopy at the University of Chicago Medicine talks about lung cancer and the Monarch System.
Interview conducted by Ivanhoe Broadcast News in August 2018.
I want to talk a little bit about lung cancer and diagnosis.
Dr. Hogarth: Sure.
Right now for our viewers what is the best way and what is the gold standard that doctors diagnose Lung Cancer?
Dr. Hogarth: I think it’s important for people to realize several things. One, lung cancer screening is now here and if you are a patient who has had at least thirty years of smoking a pack a day of cigarettes you should talk to your primary care physician about it. There are other additional criteria to qualify, but start by talking to your doctor. Screening has been shown to reduce mortality from lung cancer. Much like mammograms, much like colonoscopies, prostate exams etc. Sadly, instead of screening, the majority of what ends up lung cancer are kind of found by accident. The majority of lung cancer has no symptoms. And so if someone comes for a CT scan for another reason, your stomach hurts real severe for example, the ER may think you have kidney stones or appendix issues. And they may find you have kidney stones but they also discover something in your lung because part of the lung gets imagined and low and behold they found your lung cancer by accident. But equally important is for people to remember whether I find something by accident or I find something through screening the majority of nodules that are found inside a lung are not cancer, especially the smaller ones. So yes, if we find a nodule in you it’s concerning but it’s not a guarantee that it’s one thing or the other. And in some cases the small ones we follow them on repeat CT scans and there are some various blood tests that can get done to determine if there is an infection. But if the nodule is a certain size or there’s certain characteristics of the nodule or you the patient have certain characteristics we talk then about a biopsy. Because we can do all kinds of scans and I can talk up and down about the probability of a cancer but that’s all this is. In the end it’s a good guess. And I’ve got tools that help me get that guess better but it’s still a guess and until we have a piece of it I don’t know what it is. That piece is called the biopsy.
You do have tools that help you with this diagnostic process but they’re not perfect?
Dr. Hogarth: No they’re not. In the end when we see something on a scan it represents the probability of cancer. There’s actually a long list of things that this nodule could be but in reality what I tell patients is really there’s only two things. Cancer and everything else because the everything else is usually pretty easy stuff. It’s only cancer that is scaring the person. There are characteristics on the CT scan that make me more worried or less worried about cancer. The size of it matters, how it appears on the CT scan. Your age, your risk factors in regards to smoke, second hand smoke etc. But we also know that nonsmokers can get lung cancer. And so we have to be worried about all nodules. And it’s that degree, at some point the concern that this might be cancer is what will propel us to some form of a biopsy. Because no matter what tool we use in order to get a piece of this nodule there’s some level of invasiveness. Sure the level of invasiveness might be, less to more but we still have to poke and prod at you. And I don’t want to do that unless we need to. And thankfully for a lot of the nodules we find the majority of those are going to be normal. They’re going to be nothing; they’re going to be a scar. If your nodule is small, you will get a follow up CT scan. Although you’re nervous about having to wait, most of these nodules won’t be cancer. Furthermore, even if that small nodule is actually cancer, it will just be a slightly bigger nodule on CT. If it got bigger, now I’m more worried about it because it changed. But when it doesn’t change or better yet shrinks you just avoided an unnecessary invasive procedure. It’s a complicated discussion but it’s but there are excellent guidelines to aide physicians on this subject. Those of us that are interested in nodule management and evaluation of nodules we do this a lot so, we sort of have our speeches canned out and ready to go. But we also understand that it’s a scary thing for a patient. I get it. That’s why we try to make sure they have valuable information to explain, what’s the realistic chance that this nodule is cancer or not. And why sitting on it and waiting and getting a follow up scan we’re not harming you, you’re not losing anything even if it’s cancer. But again, most of the time it won’t be cancer. And if we recommend a biopsy there’s a reason we’re recommending a biopsy: the chance of cancer may still be generally low but it’s higher than anyone is comfortable watching.
Talk to me a little bit about the Monarch, what it is and what the benefits are.
Dr. Hogarth: Can I first talk to you a little bit about the three different ways to biopsy because it will explain why the Monarch exists, is that okay?
Absolutely.
Dr. Hogarth: So if I told you, you have a nodule there’s three ways to sample this thing historically. There’s surgery, you can go and cut the thing out right? The obvious upside is if it’s cancer we’ll prove it and potentially cure you of it at the same time. Assuming you were early stage however. But surgery is obviously very invasive, and if it turns out not to be cancer though it’s great news it wasn’t cancer you just had a large unnecessary surgery. The other way is to put a needle through the chest under CT scan and ultrasound guidance. The skin is clean and number and a needle is passed between the ribs into the lung and the nodule. This is very accurate but also comes with a modest risk of popping the lung. Though these complications can be managed and in some cases the needle biopsy is the correct route to go for a patient based on the nodule location. But it’s definitely a higher level of invasiveness compared to using the natural pathway of the lung to go out to this nodule. That’s where bronchoscopy comes in. Now historically bronchoscopy had some serious limits. The scope could only go so far then some technologies came out that allowed us to get further in to the lung with some amount of guidance but they had their own limits. And the need for all regions of the lung to be reached and to be reached reliably so that we can get out to the spots, see where we’re going, pass instruments to take biopsies reliably so that when we wake you up from your procedure we can tell you what it is. Equally important, if we are inside your lungs taking a biopsy and we prove cancer, what stage are you? Did that lung cancer spread to any of your lymph nodes? I don’t know the answer to that because I haven’t sampled any of your lymph nodes yet. If I had only done a biopsy through your skin, I may know you have cancer but now I have to take you for ANOTHER procedure to sample your lymph nodes. But if we just proved cancer in your nodule, while you’re still under anesthesia, we can now sample all of your lymph nodes and prove if your cancer has spread or not. Things like CT and PET scans are not as good as an actual sample. When I assume you’re stage one versus prove you’re stage one, there’s a big difference in outcomes. So that’s where Monarch comes in, the robotic endoscope, it opened up a whole new avenue for us to get out further in the lung. And in fact that’s actually one of the first studies that was done with the device. Not just how well did it work but could you drive this thing further. So the problem with the lung when you try to pass a bronchoscope down, you can only get so far because the diameter of the airway just keeps shrinking and the scope is a fixed size. The lung airways are forgiving, you can push but the problem is you can only generate so much force with the scope because you’re literally pushing down, the scope is flimsy and as you try to push against something tight it’s not going to give. The scope will bend and bow and it’s not going to go any further. So you get some limitations. And after your scope only goes so far you can pass catheters out but you have no optics. You can’t easily see left turn, right turn, up, down. So though a lot of the technologies in the past have been essentially a mini GPS on a micro scale, you’re still doing it virtually, you’re still blind where you’re going. The Monarch system has an outer sheath that you’re allowed to drive down and then you park it in one of the main branches of the lung. And that provides stabilization. And the actuators on that continue to keep that thing from moving. So even though to me it’s not moving in the slightest, there’s a lot under the hood holding that thing in place. So that as I’m pushing and making forces nothing is happening that shouldn’t be moving. The bronchoscope slides through that sheath and I get out further: Because it’s able to generate a force that overcomes the airway resistance and go out much further. And again the papers have been published, we get out much further with this device, the Monarch system, then we have with any of the other tools that have been available to us. That’s accessibility right? I can get out now to new regions of the lung and because of the flexibility of this device I can get to spots I couldn’t get to before because of the crazy turns you have to take all while maintaining visibility so I can see, I can see where I’m going I know to go left instead of right, up, down etc. And as I’m passing instruments once I get to the spot I’ve got to take samples. I got to see where those things are going. I got to see if I have to go through a wall with a needle let’s say the nodule on the other side of a wall. Well how do I know my needle went through the wall versus down the wall. In the past you had no way to know that. I can angle the robot and make sure that needle goes right through the wall. And watch it go through the wall. And of course because it’s an open channel I can put anything I want through this. So all the instruments that we use for biopsies they’re all available to me. I can pass everything on out. If we prove it’s a cancer and you’re not going to be a surgical candidate because you have bad emphysema or whatever we can leave little markers behind inside the tumor to help guide the radiation therapist so that you can get a more intense radiation to that spot and achieve a cure without surgery. And what’s really cool is what’s coming really soon: we’ll just slide a catheter out that’s generates microwave energy and cook the thing from the inside. This is not science fiction: the catheter already exists and is under study. A fantastic bronchoscopy doctor named Dr. Michael Pritchett in Pinehurst, NC is the first to use this device in humans. The day will come soon where you were go under anesthesia for one bronchoscopy procedure you’re going to wake up and we’re going to tell you: “you had cancer. It was stage one, which we proved during the case. But you’re cured of it. Nice to have met you now go home because it’s an outpatient procedure and play golf tomorrow”
Wow.
Dr. Hogarth: Yeah, it’s not science fiction either; it’s incredible. And the thing about it is because the Monarch gives us the ability to get to spots we’ve never been before, in the end it’s a conduit. So anyone else that’s developed something to put down that conduit, an ablation catheter, any other kind of therapies, etc. we can do it because now we’re there.
How much further can you get?
Dr. Hogarth: We were able to biopsy something out on the edge of the lung. Now the edge of the lung had always been an area that you needled: its right there and why not just easily stab at it. It was definitely the shortest path. And our reliability to get out to there was pretty limited. But there are reasons from a technical perspective that you sometimes do want to get out there. Nowadays there’s the greatest advances going on in lung cancer are the better therapies that we have. Very targeted therapies. And that going across multiple tumors. And some of the immune-based therapies and depending on what the disease is. The particular case I showed you was a melanoma. They wanted to be in a study that needed more tissue to determine if some chemo was going to help them. I’m not an oncologist if someone tells me to go get more tissue I’m just going to go get more tissue. Historically that would have been a very difficult needle pass. It would have required several passes. It definitely without a doubt would have resulted in the patient’s lung popping. The lung is just a big balloon. When you try to poke from the inside you pop a whole lot less. We didn’t pop this guy’s lung we proved he had a melanoma and got all the pieces that his team needs and if he’s part of that trial great, I hope that people can help him. I think from our perspective we were able to help him in a complication free way that was a procedure and took about an hour and he went home about two hours after that.
How much of a game changer is this?
Dr. Hogarth: It’s a big one. It really is a game changer because there were spots on the lung prior to this that we could not reliably get to. And so that was good but there were a lot of no man’s land. And spots where patients were coming to me and saying, hey I found you on the internet can we have one of your fancy bronchs. And I’d look at the spot, I mean literally those is, his exact words, and I‘d look at the spots and say, gosh you do need a biopsy but I can’t get to this. I’ll try if you want me to but I know I’m going to miss. In good faith I think that’s a bad idea. I work very closely with my thoracic surgeons, they’re fantastic people. And I try very hard to make sure that they day in and day out are curing people of something not diagnosing people of something. Because noncancerous things don’t need a surgical diagnosis. Why would we put any one through that when we can prove what it is first and then go to surgery, understand why you’re going to have this procedure and the pain and so forth involved. The surgeries have gotten a world better too and the recovery is better, this is all good. But any amount of pain is not worth it if you don’t need it. It’s a big game changer because it’s an even less level of invasiveness to get to these spots in the lung we’ve never been able to get before. We focus on lung cancer but remember a lot of tumors spread to the lung. And in some cases as a single spot. They cured you of whatever your cancer was, or at least they thought they did. They cut it out of the colon or the kidney or whatever, boom one spot shows up in the lung. And everyone’s best guess it’s your cancer. And we proved that it is. Well that’s technically stage four it’s spread right? Wouldn’t it be great if we could try to do something about it on the inside without having to cut you if that will help you? We don’t know but now we have the opportunity to try. And there’s a whole wealth of opportunities for our patients. To me that’s what drives this whole thing. And I remember when I met with the brilliant engineers and software people and mechanical engineers and robotic engineers it’s very humbling. I think of myself a pretty smart guy and when you walk in you are clearly the dumbest guy in the room. To work with some ridiculously smart people and to hear what they were planning, what they were thinking and when you explain to them what was limiting you in bronchoscopy. You take some of these engineers and you tell them here’s my clinical problem, here’s what I need and give them a wish list. And asking someone to deliver you your wish list is pretty cool actually. And then to use it. In the early days of development of this device, we would do this on a model and then another time on a cadaver. And to see it now in the real world, it’s pretty amazing.
How many patients have you treated with this?
Dr. Hogarth: We’ve done 18 people so far. A colleague of mine at another university who has this as well I believe has done 38. And then another institution in Philadelphia just acquired this so they’re probably starting up here shortly. It’s definitely fresh. It’s not an everyday device and the reason I say that is a lot of bronchoscopy for example, people come and unfortunately have a thing in their lung but also have massive lymph nodes. And it’s pretty clear that if that’s a cancer it has already spread. And if it’s spread we’ll just sample the lymph nodes that’s the easiest, it’s the safest, and it’s simple. And it gets you all you need and sadly stages you at the same time. And that’s what we’re all trying to change with lung cancer screening. Avoid these late stage cancers shift you on down to early stage cancers. We’re getting there. Slowly but surely, we’re getting there.
Who would be the best candidate for Monarch?
Dr. Hogarth: Anybody who’s got a lung nodule that’s essentially a centimeter in size or larger. That’s a generic answer because clearly there’s some smaller things that based on the patient case you would pursue a biopsy but generally smaller than a centimeter, maybe down to eight millimeters. Eight to ten millimeters, maybe a little gray. Below eight millimeters almost always should watch, again with some exceptions. But generally anything eight millimeters and smaller you would watch. It’s not because you can’t biopsy it it’s because the probability of cancer is so low. Eight to ten millimeters debatable. Anything about ten is worth having a discussion about biopsies. And I think that’s where this helps shift it. Because historically if you knew how difficult it was going to be to biopsy a one centimeter lesion you might suggest watch and wait. Depending on the patient characteristic, maybe it’s a short term follow up CT scan but you know now that it’s gotten easier to do these biopsies there’s an immediate upside. Let’s put an answer to it. Let’s not do these perpetual CT scans: that’s a lot of radiation. And if I can avoid a few CT scans and prove you’ve got nothing wrong with you then that’s just awesome.
I know we kind of talked about it before but if you could step me through how the procedure goes. You were taking about it’s an inpatient procedure.
Dr. Hogarth: Outpatient.
Outpatient procedure but it’s almost like you’ve got a video game console, if you could walk me through how the procedure works?
Dr. Hogarth: Sure. You’re under anesthesia for this. You’re asleep and there’s a tube in your mouth breathing for you. Your anesthesia doctor is taking good care of you and you’re stable. I’m going to do my thing now. And my thing involves setting up the robot around you. And the robot slides through the breathing tube and right where you park it you first do the registration. So essentially the machine knows where in space you are. There’s an electromagnet field covering the patient and it tracks where the robot is moving to correspond with your CT scan which is essentially a three dimensional map of you. This merges the virtual with reality which is already augmented by the ability to see with the robot optics. And then you start driving. And the controller, I’m looking at the screens, you’re right here I’m not technically touching you, I mean the robot is but I’ve got a video game controller. Two joy sticks, a couple of thumb pads: if you didn’t know any better you’re playing your favorite video game. But it’s clearly more serious than that but it always does make me laugh. I am from that first generation of video games. I was always being told that all the video games I was going to be playing as a child were rotting my brain, blah, blah and here I am literally holding a video game controller in my hand providing medical care. The irony is fantastic. But all kidding aside you drive. You hold the controller, you go forward, angle it around. I mean it’s quite literally like a first-person shooter video game in the sense of the response drive where you need to go. You know where to go you’ve looked at the CT scan but the machine is helping to guide you to go left, go right, go up, go down, head to the spot where you need to go. And of course since you’ve got the optics drive right down the road. Take a turn, go down a little bit, go forward, angle and up this way. And snake your way through. Because remember the lung keeps branching and branching and branching and branching. And that’s always been its problem. You know when you do an upper endoscopy or colonoscopy there’s only one way to go. There’s no turns, you angle but you don’t just choose to go down the right or the left side. The darn lung just keeps branching. And so and that’s what’s always made the outer parts of the lung, the outer third as well as the middle third pretty difficult. The inner third is going to be centered around spots that you can easily see with the old traditional bronchoscopes.
But it’s the spots in the outer…?
Dr. Hogarth: The outer third we used to have a very hard time getting to, now that we can get to. The middle third we were pretty good at with the prior existing technologies. We think we’re going to get even better with this.
If you can explain how you’re getting those optics, how you’re able to see where you’re driving.
Dr. Horgarth: Sure. I have a tube with a camera on it. There’s literally a camera, it’s got a light and it’s got a suction port so any of the goo that’s in the way I get it out of the way. And it’s shining the light and I’m driving and of course it looks like a tube. And I get to a branch in the tube and which way do I go. And of course I’ve got a map and the electromagnet thing says, hey the thing is that direction. So when your car tells you to turn right on your GPS or on your phone. This thing doesn’t tell me to turn right but it’s got a big old line going that way not this way. And so I’m pretty good at following directions so I do that.
Right now purely diagnostic but down the road because the way this system is set up you envision more?
Dr. Hogarth: Therapeutics for sure. And it’s not “if”, it’s just when.
That was my next question. Any time frame any estimate when that will be the next thing?
Dr. Hogarth: It will be coming very soon.
Where ablation will be the next step?
Dr. Hogarth: The Monarch system is the conduit to the lesion. But any company that manufactures a device that fits down the scope will work down the Monarch. The microwave ablation catheter being studied right now fits down the Monarch.
Is there anything I didn’t ask you?
Dr. Hogarth: So far the safety record is impeccable. Limited number of human cases to date but that being said as fancy as all this is if you really boil it down it’s just a bronchoscope, right? I mean don’t get me wrong it is ridiculously fancy but all I’m doing is taking a scope and snaking it out in to the lung. We used to go far in to the lung, we would do it blindly and take our best guesses. So taking biopsies is something we’ve done for quite some time. This is just letting us do it more accurately. If anything we think our complication rates might be lower. We haven’t proven that, but our complication rate, the popping of the lung, is less than two percent so far.
Life saving in your mind?
Dr. Hogarth: Life changing, I hope life saving. It definitely will be for the individual that we prove early stage cancer and then they can get surgery or radiation to cure them. Early stage is always better for any cancer but especially lung cancer. Our chemotherapies and all that have gotten a world better. The targeted therapies and all of the immunotherapies, it’s amazing. It’s exciting times in the whole field of lung cancer. Every aspect of it. But no matter what early stage is always better than late stage. Our therapies have gotten better for the late stage patients. There’s a lot more we’re doing for these people. It’s awesome. I mean my medical oncologists are fantastic people, the group I get to work with. But, it’s always better if they never need the medical oncologist right. If you just need the surgeon to cut the thing out is always more awesome.
I want to ask you again about the importance of screening, we always hear about breast cancer screening but you did not hear that much about lung cancer screening. First of all is that changing and if so why?
Dr. Hogarth: Its definitively changed. Landmark study proving for patients, tens of thousands of patients getting screened yearly for several years, a twenty percent reduction in mortality. Twenty percent from just getting the annual CAT scan, a low dose CAT scan. So very low level radiation. Why is it so important, I mean should be obvious that a twenty percent reduction in mortality sounds inherently important. This year we’re going to lose this many people from lung cancer, men and women combined, this many people. If I add up all the women that we’re going to lose from breast cancer and the men and women from colon cancer and the men from prostate cancer this is how many. We’re going to lose more people from lung cancer, dead, than all the other cancers that are the major killers combined. That’s ridiculous. We have nothing for these people. We knew that lung cancer was bad, we knew that you always presented late stage. But early attempts for screening for chest x-rays were a complete failure. There had always been the assumption that CT scan would make a difference but you’ve got to prove it right. You know what happens when you assume. Now the question then is who is right for screening. There are specific criteria on who should be obtaining a CT scan for screening. For screening purposes. There are guidelines on what to do with the findings on CT scan. Most nodules found are not cancer. That’s an important thing for people to understand. I frequently hear people say, well I’m scared to get the CAT scan I’m worried about what they’ll find. I understand that fear but it’s an irrational fear to do nothing about it. Because what will happen is if you do nothing about it and you don’t get screened and you do develop a lung cancer we’ll find it eventually. But we’re going to find it at a stage where we’re only going to have limited options of helping you. And because we’ve got such better tools to help with the follow up and we’ve got better tools to help with biopsies, we’ve got better guidelines on what to do with these nodules when we find them. There’s a strict kind of almost algorithm approach on how to help you and what to do to help you so that if it’s something benign or hoping to avoid unnecessary invasive procedures. And if you need one we’re going to do the least amount of invasiveness. And then if we do find it then we’re going to be able to alter your outcomes. Because if you are somebody with an early stage lung cancer found through screening you would have been found eventually. A couple years later when you’re advanced stage and just statistically not going to live much longer afterwards. Whereas if we found you now, cured you of it your life expectancy is whatever it’s supposed to be. And it’s not going to end because of lung cancer.
Lung Cancer screening covered by insurance in most cases?
Dr. Hogarth: Medicare for sure, commercial is the usual crap shoot.
One of the questions about the Monarch, do you have any ties to the company?
Dr. Hogarth: Yes I do. My consulting work with Auris was disclosed to my university and I list it with my papers and presentation etc. I was a paid hourly consultant and received an hourly fee for travel and then also received stock options in the company. Essentially equity in the company for my work.
I think I got it all.
Dr. Hogarth: For what it’s worth, we haven’t mentioned other people’s tech but I do consult for other technologies if that matters. So we have full transparency. They’re in this peripheral bronchoscopy space if you will. Like one of Monarchs competitors is Medtronic’s super dimension and I’ve consulted with them and have worked with them. There’s also LungVision by BodyVision, a technology that I have a consulting arrangement with as well.
END OF INTERVIEW
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