0:00

So we talked about, uh, some of the clinical indications,

0:03

how people are using it, some of the data.

0:06

Now we're gonna talk about

0:07

where things are headed in the future.

0:09

Um, there are three main areas that we're talking about,

0:12

which is breast cancer screening, using contrast mammo, um,

0:16

in the diagnostic setting just

0:17

to formalize those indications a little bit.

0:20

And then radio mix, which is AI and machine learning

0:23

and really, really neat stuff is happening.

0:26

So we'll talk about breast cancer screening.

0:27

This is, um, this is a topic that I think most of us

0:32

who use contrast mammo, most of us, most people who, who

0:35

see tox on contrast mammo.

0:37

This is the area that we're most excited about, especially

0:40

for women who have dense breast tissue who are at high risk.

0:43

Maybe they don't qualify for an MRI

0:46

can we do a better job at finding breast cancers

0:50

for these women above what we're already able to do

0:52

for tomosynthesis with tomosynthesis and ultrasound.

0:56

So this is a patient, um, who has,

1:00

is high risk for breast cancer.

1:01

She had a contrast mammo. This was a screening exam.

1:03

You'll see the, um, low energy images were negative,

1:06

and then we do the recombined images

1:08

and we can see, um,

1:10

a hormone receptor positive cancer in the right breast.

1:13

And so this is kind of what we're talking about.

1:15

We're talking about identifying cancers that we would

1:18

otherwise miss on our conventional imaging.

1:20

I mean, this is, this is why we're excited about MRI.

1:23

So, um, the problem is that the data is, uh, is not

1:28

yet there where we can do contrast mammo for screening.

1:31

Certainly it has not been FDA approved for this indication.

1:35

So let's talk about the data.

1:38

Um, we have retrospective studies, reader studies,

1:41

and then there's SE seima, which is really, really excellent

1:44

that have already been, um, seima is, is happening now.

1:49

But there are some retrospective

1:50

and reader studies that are out.

1:52

So Soren in colleagues in 2018

1:56

compared contrast enhanced mammography, the full exam,

1:58

low energy and recombined images to, um,

2:01

the low energy alone, which is kind

2:02

of a surrogate for mammography.

2:04

And they found an additional 13

2:07

breast cancers per thousand women's screened.

2:09

2019. The MSK group looked at their data

2:13

for contrast mammo, and they found a cancer detection rate

2:16

of 15 per thousand women's screen,

2:18

which is much higher than the standard, uh,

2:20

cancer detection rate rates.

2:22

We typically talk about with mammo

2:24

or with tomosynthesis, which is about, you know, three

2:27

to five, three to six breast cancers per thousand.

2:30

There are also retrospective studies on, uh, women

2:33

who have had a history of breast cancer, those

2:35

that are above average risk.

2:37

Women who have dense breast history of lobular neoplasia.

2:39

And they all say the same thing, which is

2:41

that contrast Mammo does a better job than conventional.

2:44

Mammo, though is really gonna be, um, the test,

2:49

the trial that helps differentiate.

2:52

Should we be doing this?

2:54

It's a prospective trial, it's a multicenter trial.

2:57

What Seamless is doing, it's recruiting about

2:59

2000 women.

3:00

These women are getting both tomosynthesis

3:03

and contrast mammo.

3:04

And it's gonna be able to see

3:06

what the difference is in cancer detection

3:08

and also what the difference is in false positives

3:11

because that impacts, um, our view

3:13

of whether this is a good screening test.

3:15

And they'll track, um, you know, contrast reactions

3:19

and what, so that we can really get an overall look at

3:22

how this modality plays for women

3:23

who have dense breast tissue, the good and the bad,

3:25

and compare it and see if this is something we wanna do.

3:29

The results of that should be out in a few years.

3:30

It's very exciting. Uh, stay tuned.

3:35

My group published, um, a trial more recently

3:39

that compared contrast enhanced mammo to MRI

3:41

for breast cancer screening.

3:42

We had 132 CEM

3:45

and MRI exams in an asymptomatic, uh, population

3:49

of women 132.

3:50

That's a huge number. And we had 12

3:52

equal 12 radiologists look at all of these exams

3:56

and we compared the performance metrics.

3:57

And what we found as expected is

4:00

that CEM performed a little bit worse than

4:02

the full MRI protocol.

4:03

You can see CEM sensitivity was 89%,

4:05

whereas the full MRI was at 94%.

4:08

But look at the sensitivity of 2D mammography, which was 70,

4:11

75%, much lower.

4:14

Um, we found that the specificity

4:16

of contrast mammo was higher than the full MRI protocol,

4:20

which again, is what we'd expect.

4:22

Fewer false positives.

4:23

When we see something on that on the MRI,

4:25

on a contrast mammo, it's more likely to be breast cancer.

4:29

And when we look at that metric of accuracy, which is a,

4:32

you see, to see how, what the balance is

4:35

between cancer detection

4:37

and, um, not finding benign things, we see

4:41

that actually the the accuracy is very similar

4:44

between both of these exams.

4:47

And we confirmed that

4:49

contrast enhanced mammography is non-inferior to breast MRI.

4:53

And this was great. I mean, we looked at a lot of cases

4:55

and we had a lot of people look at it.

4:56

And so this helps perpetuate the idea, move forward.

5:00

The idea that these two exams are very,

5:02

very similar overall, unfortunately, again, as I mentioned

5:06

before, we don't have enough data yet to, um,

5:09

to really embrace this fully for breast cancer screening.

5:13

Certainly the organizations that guide us have not done so.

5:17

And so really, um, where we're at

5:19

for screening is the a CR has acknowledged that

5:23

CM has value, but that there's limited data.

5:26

And so it's really only recommending it when MRI

5:28

cannot be performed.

5:29

I imagine this will change over time,

5:31

but this is where we stand today.

5:33

The NCCN, which is the National Comprehensive Cancer

5:36

Network, has a similar approach.

5:38

Really use contrast mammo

5:39

for breast cancer screening when you can't perform an MRI.

5:43

Same thing with US obi,

5:44

which is the European Society of Breast Imaging.

5:46

So that's kind of where we're at.

5:48

I imagine that will, um, things will change over time,

5:51

as I mentioned.