11: Move Over Mammogram! QT is here.

Hello and welcome to the Kenya breasts podcast with Dr. Jen. The show dedicated to empowering women through knowledge, tools and resources to take control of your breast health journey. I'm your host, Dr. Jen Simmons, and I'm thrilled to have you join me on this insightful and inspiring journey. As a breast cancer surgeon turned functional medicine physician, I'm on a mission to empower women to live their breast, I mean, best lives. This podcast dives deep into all topics related to breast health, including prevention, diagnosis, treatment, and holistic approaches to support overall well being. You know what I say? Breast health is health. So no matter who you are, a breast cancer survivor, newly diagnosed in treatment, living with metastatic disease, or you're simply seeking to improve your breast health, this podcast is for you. Join us on this transformative path towards better breast health and a thriving life. And now, let's get to today's episode. Hi, it's Dr. Jen, and welcome back to another episode of Keeping Abreast. I have a really, really special guest today, a man who is just. He's brilliant, he's a genius, and he is actually going to change the way that we image in the future. He has been charged with an enormous task of solving our imaging problems, and he solved them. I am delighted to introduce Dr. John Klock. Dr. Klock is an internal medicine physician. He's board certified in hematology, oncology, immunology.

He.

His accomplishments are so vast that I can't begin to name them all. But for people who have gone to have a calcium score, he is the reason why you can go have a calcium score, a virtual colonoscopy. He's the reason why you can have a virtual colonoscopy. And he just continues to up the game and up the game and up the game. And I am delighted that he has found time in his schedule to be here today to talk with us. Dr. Clock, welcome.

Well, thank you so much, Jen. That's a very big introduction. I'm sure I can't live up to it, but it's a pleasure to be here.

I'm 100% certain you will. So let's start off with how you went from being a hematologist, oncologist to making this shift to developing imaging systems. Like, how does that happen?

Well, it's very interesting. You know, I, I came from academia and I left academia because, you know, I saw the best way for me to really make a change in medicine was to be in what's called translational medicine, where you're translating science into FDA approvals and Clinical adoption. So that was the first thing. The second thing is that the biggest problem in medicine today is access to medical imaging. There's 7 billion people in the world, but 5 billion of them have no medical imaging. So that's a huge challenge. Plus, I think the most important tool that a doctor has these days, wherever you are, is access to medical imaging. When you go see the doctor, generally, one of the first things they do is order a test of some kind. And so it is hugely important for patients. It's hugely important for being able to find out what's going on with people. So I took that on as a challenge. And with the National Cancer Institute, they gave us $20 million to develop a new imaging technology which could improve the outcomes, improve the sensitivity, reduce the risk factors associated with radiation, which is in basically all medical imaging, and to really try to make it accessible to more and more people in the world. So those are the reasons.

So let's start talking about why that was necessary. The most common test that's done right now for screening in terms of breast is mammogram. So why does that need to be replaced? What's wrong with the mammographic screening system?

Well, when we met face to face with the fda, the mammography people at the fda, they told us that really the problem is serious adverse events. In other words, one of the big challenges of the public health system is to try to keep medicine safe and effective. So serious adverse events are really what you hear about all the time. You hear about drugs being removed from the market because of adverse events and so forth. So most people don't realize mammography has serious adverse events. These include misdiagnosis or missing a diagnosis, especially in dense breasts. It also includes callbacks and unnecessary testing. And finally, there are financial challenges for some women with the system when a lot of the callbacks are not covered by, you know, their healthcare plan. So the FDA asked us to work with them to specifically address these aspects.

Of it in terms of serious adverse events. You listed misdiagnosis, missing a diagnosis, callbacks, unnecessary testing, financial challenges. What about the fact that mammogram utilizes ionizing radiation in order to create its image? Is that a concern?

Well, the medical literature supports the fact that there are thousands of cases of breast cancer every year in the United States as a result of the X rays from mammography. That's a statistical number. Of course, it's done using complicated mathematical modeling. But I think that the breast is a radiation sensitive tissue. Women who have chest radiation or lymphoma or other types of things. Very high incidence of breast cancer. I think it is a very important aspect of it, especially if it's something women have to get in a lifelong fashion, so to speak. And for younger women who are at high risk, this is very serious potential challenge for them.

Yeah. And you mentioned people who are treated with. With radiation for lymphoma. And a very high percentage of them, somewhere like 25% of them will go on to develop a breast cancer somewhere 15 to 20 years after they were treated with radiation for their lymphoma. Right. And so we know that radiation is itself a carcinogen. And then as you pointed out, there are thousands of cases every year that result directly from mammography. And we should mention that in the genetic mutation population, people with like a BRCA mutation, those people are even more sensitive to the damaging effects of radiation. And for those people who we. They get put on these accelerated imaging schedules, right. They start imaging earlier and they have more frequent imaging. So now we're delivering even more radiation to that population of people who are already more sensitive, and we're probably causing cancers in that population.

That's a very long statement, but I have to agree with it. So that's pretty much all I can say.

Let me ask you, because this has been proposed as an alternative for at least the dense breasted population, the BRCA population. Like, what about mri? Why isn't MRI a solution?

Well, I think MRI is a very good imaging technology. You could say it's the gold standard. What we've developed is 40 times better than MRI. So specifically, the National Cancer Institute was very happy with that. But I think that MRI has big challenges. There are several. One is that it does involve a magnetic field, which does have some health problems. It involves an injection of a heavy metal which is required to get very good pictures. And that heavy metal doesn't really get eliminated from the body. So over a long period of time, that's a potential health hazard. And I guess the other problem with MRI is it's almost too good. There are a lot of false positives when you inject gadolinium. A lot of things light up like light bulbs in the breast tissue that are not really a problem. So I think that put together, well, the final one, I guess, is that breast MRI can cost from 2,000 to $10,000, depending on where you are and what your market is. So it's a financial challenge for women as well. So I won't mention the fact that it takes a long time and it's A very uncomfortable position that most women are placed in. But I would say, because you have.

To lie face down, right? And the average study is over 30 minutes.

Yes, 45 minutes or so. And I think that the bottom line is that if you look at women with breast implants, for instance, who are recommended by the FDA to get MRIs every other year, fewer than 1% of women really do that. And I think that speaks very clearly to the fact that this is not an alternative that women want to go through on a regular basis. And I think that there's a big push by industry, of course, to do this, but I think, you know, a safer, more comfortable and. And better test, it certainly would be helpful.

And what about access? Is access to MRI an issue?

Yes. We're told by. By practitioners and even the manufacturers that the wait time for a breast MRI in an uncomplicated case is six to nine months in many markets. So there are not enough MRI machines in the world to do screening with mri. It's just. It's just almost an impossibility just because, you know, you can only do so many per day in your center.

So you started to allude to this in the beginning. We obviously have issues with our current breast screening practices. Right. Mammogram has its limitations. It has limited sensitivity, limited specificity. It will miss 30% of cancers in a dense breast, and it involves radiation. It's painful. We didn't speak about that part. I mean, I know plenty of women personally who won't get the test for no other reason than she doesn't want to have her breast smashed down to a centimeter's depth in between two metal plates. So it's painful, it's uncomfortable, it's anxiety provoking, because you don't know if you can trust the results or not. So we know there's a lot of problems with mammogram. We know there's a lot of problems with mri. It's uncomfortable. It takes a long time. It involves heavy metals, a magnetic field. So you were charged with finding a solution to this. So tell us about that process and what happened.

Well, I think that the grants from the National Cancer Institute are certainly a statement of their confidence in what we're doing. The FDA clearances were also a statement in the confidence of what we're doing. I think that women did a very good job in 1983 of having the MQSA laws passed by Congress. These MQSA laws were passed because mammography was irregularly accurate. There were so many centers and all kinds of variation and quality and so forth. So they were put in place for a good reason. However, the side effect of the MQSA laws were the fact that women also requested randomized trials to be able to get these things approved by the fda. And the bottom line is that mammography was grandfathered in without any trials whatsoever about 50 years ago, and there's been nothing approved since then because of the MQSA laws. To be able to do a study, for instance, in young women with dense breasts who have BRCA gene mutations, you would have to probably take a lifetime of following these women. You'd have to end up with tens of thousands of women in the trial. The trial would cost over $100 million. No one's going to do that. So we're working with the FDA under our breakthrough device designation to come up with a more novel trial design to allow us to do that. So I'm hoping that we'll be successful this next year or so with the FDA and giving broader clearance. But there are scientific and regulatory obstacles to replacing the mammogram. And I think that it just should be stated that, you know, the only other way to really solve this problem is to do what we're doing in California, which is direct to consumer access to breast imaging. So that would be.

Can you. Can you tell us a little bit about what this imaging is that you're talking about? Because people don't know.

Good question. Well, I think that the best way to explain it is that it uses sound energy, but it uses sound energy just above the spoken word. So we're not talking about crazy radiation or anything like that. It's just sort of bats can hear what we do. So that very low dose of the spoken word, or maybe very high frequency spoken word, is transmitted through the breast.

Like my mother when she's angry.

Yeah, that's true. That's a good point.

Thank you.

The woman lays on a table, a very quiet room. Her breast is in a warm water bath because you need that water to be able to conduct the sound through the woman's breast. So that's all that happens. Basically, the woman is there for four to six minutes, and the sound machine goes around in the water, and there's no sensation whatsoever. About half the women fall asleep. It's that comfortable. And then it develops beautiful pictures of the breast tissue, all the breast tissue, the glandular tissue, the ductal tissue, the blood vessels, the nerves. I mean, everything. So that's the pictures that we look at. And it's just a really beautiful image Set.

So what are people saying? For instance, I know that I spoke to someone and they said, oh, whole breast ultrasound has been out for years and this isn't novel therapy. What is your response to that?

Well, I would say this is not ultrasound in the way that we think about it. It is a different kind of energy. It's a different kind of way to acquire it. This comes out of the oil exploration technology where they use the same thing to find oil. And this is why we have so much more oil being discovered in the world today and why we don't have a shortage anymore because of imaging. So we just took that technology. It's completely different than anything that's out there. And it's very hard to explain to people how it's different. But, you know, scientifically, if you look into it, I think it's very clear that it's different.

The images that you're getting from whole breast ultrasound are still fairly limited. Right. Whereas the images that, that you're creating with QT imaging, I think you mentioned before that they have 40 times the resolution of MRI.

That's correct.

What kinds of things are you able to see with this imaging? And what is the sensitivity? Like, what's the specificity, like, what results are you seeing with this imaging?

Well, I think the best comparison is that this can replace mri. It can do whole body imaging, it can do orthopedic imaging, bones and joints. We've published all this information, so handheld ultrasound cannot do that at all. The second thing is that this can look down to the level of individual cells and tissues. So we have the ability to look at very, very fine detail, things that have never been seen before. And finally, I would say it's what I call functional imaging. It actually can determine what's the tissue is doing, that is what its growth rate is, what kind of tissue, where it is. So for instance, you can find a spot on someone's QT scan and call that person back in just a few weeks and find out if it's growing or not. So that's something you cannot do with any other type of imaging, really. And so now we're looking at the biology of breast tissue, whether it's something that's important, whether it's stable or going away. Because a lot of things in the breast come and go, lumps come and go, and sensations come and go. And this is part of the normal changes that happen in a person's body. So we can follow those and look at those. And we are publishing that data right now. So I think that's another aspect of it that's going to be very important.

Can you just review again what the process is like from the patient experience? So what is happening with them? Most women, part of the dread of going to get a mammogram. Yes, of course. It's what if it finds something? But it's also the whole process of getting a mammogram, which is very painful, very uncomfortable. Even though it's relatively fast, it is still a very much a dreaded procedure. And also an mri, though an MRI is not painful, it's a dreaded procedure. It's noisy, you get a headache, you're uncomfortable, it's long. So can you describe what the patient experience is like with qt?

Sure. Well, first of all, the centers where we do this imaging, they're like a spa. So the first thing is they walk into a center that's not a clinic. There's not a waiting room with a bunch of people around in gowns. And, you know, there's tension in those rooms also. But so that's the first thing. The second thing is they do put on a very nice gown that you would have in a spa, and they go into the room, they're placed on the scanner, they just lie down on their tummy for a few minutes, and there's music in the room. It's quiet. I mean, it's designed to be a very comfortable experience, more like being in a spa. And we did that on purpose because this should not be something that women are afraid to do. The procedure is quick. Depending on the size of the breast, of course, it could be as short as four minutes or two minutes. It could be as long as eight minutes or 10 minutes. And then you're done and image is processed. And then, you know, you get a result, and the result that you get back, it's very important. You don't generally get a callback letter. The callbacks are anywhere from 10 to 15%, depending on the statistics that you look at in the mammography center. So not getting that callback is a huge plus for women. So, for instance, if you have a cyst in your breast and you get called back from the mammogram because the cyst just looks like a shadow, we can determine whether that's a cyst right away without having a callback. So for a large percentage of women who have breast cysts, and, you know that's a fairly high percentage, especially young women, that callback is eliminated. So I think these are all things that added together, I think really give Women a good experience. We've just done a study of almost 500 women. We had both the mammogram and this QT ultrasound or QT imaging test. And 99% of them said they would prefer the QT imaging system test. So I think we try to do some objective things again for, for the FDA and for academics and for practitioners to show that this really is something that is preferred if women have a choice.

So where do you see this technology fitting in in the current landscape?

Well, I have to say personally, you know, I've been doing this for about 12 years personally. My objectives are to really provide imaging that is safe, low cost, more accurate than what's out there to virtually everybody. And I know that sounds very democratic and so forth, but I do have a heart for people not only in the third world, but in low resource areas in our country that don't have access to medical imaging. So that's my overall goal. We started with breast imaging because it is one of the biggest challenges in medical imaging today. But we do have a very clear goal and purpose to expand this. For instance, we've done infant scanning and there is nothing to really scan infants today. This will revolutionize, of course, pediatric care and newborn care and newborn screening. These are the kinds of big ideas that we have that we hope we can really move forward with.

So I just want to hit the highlights so that people are clear that this test does not involve ionizing radiation, right?

That's correct.

It's fast, it's relatively inexpensive. Certainly compared to an mri. It's very inexpensive as compared to an mri. It's comfortable, it's a pleasant experience and it's definitive. Am I, am I, am I incorrect in any of those?

You're correct. And I think I do have to be careful because you know, we're not allowed to say, the company is not allowed to say that it's a replacement for a mammogram at this time. But women can certainly make that choice and self refer. And I would say of the 15,000 women that we've scanned so far, more than half of them have been self referred because they don't want to have a mammogram. So I think certainly we're open to help anybody that wants it.

I do want to talk a little bit about what happens when you see something on one of these studies in that if you screen a certain number of women, you are going to find breast cancers, fairly common disease. So what do you see on these scans when there is a cancer there and then what Would the next step be?

Well, first of all, I think women need to know that breast cancer is highly curable. Today, most women who are diagnosed with breast cancer, it is localized to the breast. And as a breast surgeon, you know that the changes in managing breast cancer are very positive for women with less invasive, less disfiguring technology procedures being done. So that's good. And I think that women need to know also that a lot is happening in the treatment world with non chemotherapy regimens, curing breast cancer with, you know, cancer gene drugs and immunotherapies and so forth. So I think first of all, women need to be encouraged that the diagnosis is not what it used to be. It used to be almost a death sentence. So that's changing. But for women who have breast cancer, then one of the real advantages of what we do, and I see breast cancer almost every day, unfortunately in our clinics, but the test is being more accurate, gives you a better picture of what is going on in your body and really helps the doctors minimize the procedures that you need to have. But it really is something that is a very standard way to approach the diagnosis and the management. And you know, there are different practices, there are different community standards, but certainly I think women, you know, can have a faster, better diagnosis. And you know, with newer technology, like.

Anything that's new, people often fear it and discredit it. Can you tell me a little bit about the reception that you've had for this technology?

Well, I think there are two camps, so to speak. There are people that do embrace new technology. There are people that see problems with current healthcare practices or the forward thinking, forward, you know, looking physicians and patients, they certainly embrace it, they're very happy with it, and we're certainly getting good results. And then of course, there is medicine, which is a business now. I mean, it's just amazing that the number of hospitals and doctor practices that are now owned by Wall street hedge funds, and that says a lot about change in our medicine. So if you are a business and you're making good money on mammography, of course you don't want to change that. And that's a natural thing. Most radiologists, most breast radiologists now work for these companies or major hospital systems. So there is a lot of resistance to it, I would say, to be fair. But I think with time, as this comes to be seen as something not to be feared and a real advantage over what's out there, it will eventually change, but it does take time.

Yeah, I really think this is going to come down to being all about the women. Certainly in the breast imaging arena, I think that the orthopedic and the pediatric part will follow very logically. But I think like, like most huge movements, it's going to be about the women and driving this. And it's time for people to know that the decision is theirs and that the options are there, better options are there. And you have the opportunity now to not have a painful procedure, not undergo the trauma of it, not get radiated every year, which we know is causing more cancers than lives it's saving. It is so comforting to know that this option is now here, at least for me and my community. We are tremendously excited about it. I'm so hopeful that women will take control of this situation and ask for what they deserve rather than just accepting what they're given. Tell us where you stand in terms of FDA approval for this.

Well, we do have five FDA clearances, including breakthrough device designation. We spent many millions of dollars doing blinded randomized trials against mammography. One of those is being published. The second one is, is going to be published very soon. That is very strong scientific evidence that what we're doing is certainly not worse than mammography. In fact, the callback rates are lower, sensitivity is higher, specificity is definitely higher. So there is science to support it. These are peer reviewed publications, so published in academic radiology journal. So people should know that's the background. But I completely agree that women need to take control at this point. They took control during the MQSA time in 1983, a little bit of over control from that. But I do think you're correct that women will be the drivers of the new technology for this type of imaging. And I'm certainly hopeful and I certainly thank you for your support and trying to move it in that direction.

You did mention trials against mammography. What about trials against mri? Where does this stack up? How does this compare?

Well, I think that first of all, the fda, I didn't really answer your question, but the FDA clearances we have are for making transmission and reflection images of the breast. Right now it is cleared for women with dense breasts because if you had, you don't know that you've had a dense breast until you have a mammogram. We're not displacing the mammogram in those women's situations. The breakthrough device designation is something we have to complete studies for, but that's designed to provide a replacement for the mammogram or for younger women, let's say from 18 to 30, who have cancer genes or who have strong family history where they can't get mammography because of its side effects and the radiation. So I think.

But the truth is that population of women should also not be getting mammography. First of all, it's not a sensitive test in that population. In the dense breast population, it's not a sensitive test. And in that population of women that have genetic mutations, they are even more sensitive to the radiation. So if we start radiating them at a younger age, 35, 30, we are only compounding the issue that they were born with.

Yes, you're correct.

We're almost guaranteeing those women a breast cancer by doing that, by taking that approach. This really does solve that issue for them. Then I never really understood using a test that causes cancer to screen for cancer. This is a solution that, that is a hot topic these days, the dense breast topic. People have a lot of fear around being designated as having dense breasts. And I believe that fear is only compounded by the fact that our current imaging has been so unreliable for them.

Yes, well, I didn't really answer your question about mri. I think that we're not planning on doing head to head comparisons with MRI because I think we know our own statistics and we know MRI statistics. We're happy to have other people look at it. What I would say is that we see breast MRIs every day and compare them to what we're doing. And generally what I would say is that there are a lot of things that show up on MRI that are nothing. They don't mean anything. So I think what we would find is a high false positive rate with MRI, which other people have found. What we are doing with a grant from the Susan Love foundation in Los Angeles, is a study of women, younger women who have dense breasts who have negative mammograms. We're now doing a study showing really that those are not really negative mammograms. And I think that's more valuable in terms of trying to help women. Because, you know, what we really want to do is help the average woman. And as you know, the average woman, even when it's recommended, does not normally go for MRI screening. It just has a whole bunch of problems that women know about. So we don't really want to draw on a population of women who would be doing MRI screening. We want to draw on a population of women who are not being served.

You know, that MRI issue is an issue for a variety of reasons. I mean, it's an access issue, but I mean, for someone like me who's allergic to gadolinium. I'm not going to go have an mri. I'm not going to premedicate for it. Like, I'm just not going to do it because I have so much anxiety about being allergic to gadolinium and not wanting to put more heavy metals in my body, especially when I already know I'm sensitive. And I'm sure that I'm not alone in this. Right. So that the reasons that people are not getting MRIs are vast. So it's such a relief to know that there is a very viable alternative. And I really do hope that women hear this and are part of that movement to get away from something that is going to hurt them and help to embrace this technology. That is all the things that we talked about before that is safe, that is effective, that is fast, that is comfortable, that is sensitive but specific at the same time. So highly reliable and reproducible and all of those things.

So.

So, Dr. Kolak, if someone wanted to get a QT scan now, where are they available?

Well, we just started really placing these systems this year in 2023, about 10 centers in the U.S. but we just put one in Beverly Hills a couple of weeks ago. So we are developing it. We're going to put one in the largest cancer center in Canada in a month or so. You know, we have three or four centers outside the U.S. but it's a, it's a slow process. We've just signed an agreement with a very large medical instrument imaging manufacturer, can't tell you who that is right now, who are going to help us distribute this in the US and worldwide. So I do think it's coming. But at the moment, you'd have to either go to LA or Scottsdale or San Francisco or, you know, hopefully there'll be something in Philadelphia area in the.

Next year very soon.

And, you know, we do have customer discussions and in the Deep south and in the Midwest. So, you know, it will be happening and. But unfortunately, it's not on your neighborhood, you know, medical.

Well, it will be. It will be. Dr. Clark, thank you so much for sharing this with all of us and for doing what you do and making the world a better place. And I know that this is going to be a legacy that you leave to the world and without question will make the world a better place. So thank you so much for all that you do.

Well, thank you for your support and good luck.

Thank you. It's Dr. Jen. Bye for now. Thank you for joining me on this episode of the Keeping a breast podcast with Dr. Jen. I hope you found the discussion informative and empowering. Remember, breast health is health, so by staying informed and taking proactive steps, you have the power to optimize your well being. My team and I encourage you to apply the knowledge gained from today's episode to make positive changes in your life and share what you've learned with others. If you enjoyed this episode, please subscribe to our podcast and leave us a review. Your feedback and support mean the world to us and help us to reach more people who can benefit from these conversations. Stay connected with me on social media where I share additional resources, advice, updates and announcements related to breast health. You can find me on Facebook, Instagram and YouTube. Dr. Jennsimmons and remember, my Jen has two N's, so until next time, remember to stay proactive, informed and confident in your breast health journey. The key to your health is you.