Precision Surgery: New Device Improves Breast Cancer Surgery

Precision Surgery: New Device Improves Breast Cancer Surgery

(upbeat music) – Hi, I’m Rick Barth. I’m one of the cancer
surgeons here at Dartmouth. I’ve been here for 25 years and I take care of a lot of
patients with breast cancer. What I’m gonna tell you
about in the next few minutes is a device that we’ve invented that’s gonna transform the
way that we can take care of breast cancer patients
and do their surgery. One of the biggest
problems we have right now is that the methods we have to use to do breast-conserving
surgery are very imprecise. Most patients present with
breast cancer that you can’t feel so we have to use a technique
called wire localization to identify where the
cancer is in the breast. Wire localization
involves the placement of a wire in the breast when patients are awake before their surgery. And the patients come
up to the operating room with the wire in their
breast and we have to sort of figure out where the cancer
is and try to take it out. It’s not a very precise method. And in fact, 25% of the time when we use wire localized lumpectomy,
there’s a positive margin. That is, there are cancer cells at the edge of what we take out. So we have to call the patient and they have to come back
in and have more surgery. Well the patients don’t
like wire localization because they don’t like
the wire being placed in their breast when they’re awake and they certainly don’t like coming back for another surgery and having
more breast tissue removed. So, I said, there must be
a better way to do this. And so I thought, wouldn’t it be nice if I had a three-dimensional picture of exactly where the
cancer is in the breast to guide my surgery. Currently we do MRIs on patients and an MRI gives us a bit of
that three-dimensional picture. But the MRIs are done with
patients lying on their belly. And as you know, we’re
operating with patients on their back in the operating room. So our first innovation was to do MRIs with patients lying on their back. Now we had these images that corresponded with how the patients were
on the operating room table. And then I spoke with engineers at the Thayer School of
Engineering at Dartmouth, and I said, can we make
this into a 3D picture that I can then use in the operating room to operate on patients more precisely? And they gave me some navigation tools to be able to do that. So we started testing
that idea in patients. And in fact, put together a study where we studied 140 patients. Half of them had a standard
wire localization technique and half we operated on with
our supine MRI technique. We had great results. We cut the positive margin
rate from 25% down to 12%. But while we were doing
it, we still felt that this technique wasn’t so great, okay, it wasn’t perfect because it was difficult to still localize cancers
that were deep in the breast and the navigation system was
a little cumbersome to use, so that it really couldn’t be
used across the United States. So that’s when we came up
with our real breakthrough. And that’s the breast cancer locator. So here it is. Here’s the breast cancer locator. It’s a 3D printed plastic form that we place on the
breast before surgery. And what we can do is
it has little holes in the form that we can mark the edges of the cancer on the breast’s surface. And then through these ports,
we can place wires into the breast while the patient’s asleep that precisely define
the edges of the cancer. Then we take this off, okay. We know exactly where the
edges of the cancer are inside the breast tissue. We know the edges on the surface. And we still have the 3D
model that we can look in the operating room and we know exactly the distance from the skin to the tumor and from the tumor to the chest wall. So knowing that information, we can really precisely
do breast cancer surgery. We’ve tested this now in 20
patients and it’s worked great. All patients we’ve been
able to do lumpectomies and have negative margins. So our next step is to have this device tested at other centers. I’ve spoken to several surgeons about this at other centers and I can
tell you they’re very excited to be able to use the
breast cancer locator. And so we’re planning a clinical trial where we’re gonna compare
the breast cancer locator to wire localization lumpectomy. We feel confident we can decrease the positive margin rate to 5% or less, which I think is really gonna transform the way we can do breast cancer surgery in the United States. And we’d love to be able
to have you guys support us in our efforts to do this. – Thank you, Dr. Barth. That was a terrific presentation. So, I’m a breast cancer survivor. Actually, Dr. Rosenkranz was my surgeon, but I’m very excited about
this idea and the locator. So, for a woman like
me, let’s fast forward five to 10 years from now. What do you envision would be the outcome if you get the funding
we can give to you today? What do you see the result
would be for women like me? – Sure, well, first of all I’m sorry that you had breast cancer. I’m glad that you’re doing well now. – Thank you. – About 50,000 women in
the United States each year have to have re-excisions
because of positive margins. So if we can really demonstrate
that our device decreases the positive margin rate from
25% down to less than 5%, you know, at least 40,000
women are not gonna need those extra surgery,
they’re not gonna need more breast tissue taken out, and they’re gonna have
a procedure that’s done a lot simpler for them. And I really think that this device, it’s a pretty simple
and easy to use device, so it’s very applicable and I think lots of surgeons across the country are gonna be able to do this. – Dr. Barth, you talked about the form, I assume the 3D printing is developed with the individual patient. So a form is for each patient. – Right. – I’m interested in the
technology side of it. How easy will it be to
spread this technology to smaller hospitals
that may not have some of the technological capabilities like we have in CSI, with in-room imaging and things like that? – 3D printing technology
is improving daily and its got more and more applications in the medical field. What our vision right now
is that patients would have their MRI done at their local institution and then the images can
be transferred here, where our radiologists can then draw the edges of the cancer for each slice and create that 3D image. We have a central printing facility where we would print them and then we would send the printed breast cancer locators to the surgeons at their hospitals and then they could use
them in the operating room. So that’s our current model
for how we would do this. – How much of a commitment
from us are you looking for? – Our next step is this
pivotal clinical trial. Where the way we’ve designed it, they’ll be about 200 patients
in each arm of the study. 200 patients will have
the wire localization and 200 patients would have our new form. If we assume that we’re gonna
go from 20% positive margin to 10% positive margin, okay, that’s about how many patients we need. To fund a study like that, it’ll probably be about a million dollars. – Money well spent. – Indeed. – Yeah, thank you so much. – Okay, thanks. – Thanks.

One comment

  1. This is quite impressive and encouraging. I wish this was around when my mother-in-law was Dx and later quickly passed.
    Dr. Barth, I would be curious as to:
    1. How does one determine which patient gets the gift of being chosen for the new locater device, and..
    2. Is a study of 200 pts (understanding 400 total for the comparison) sufficient to provide the results you see will result?
    3. Will this be a tool that can also be used for a pt., such as my MIL who had mammograms annually, yet after a fall, they discovered she had Metaplastic Carcinoma & a Malignant Phyllodes Tumor? Stages 3 & 4, where it broke my heart to watch her go through so many surgeries to fight something that within 6 months took her.
    Please know, my questions are out of respect for what you are doing, and I am excited to know that something like this is becoming available to all women who fear the potential Dx of breast cancer. After my surgical tech. rotation, I was alarmed at how much tissue had to be removed in order to finally get to where all the positive margin was removed. Thank you for having the passion to work towards women having better outcomes when needing to have a lumpectomy.

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