Q & A with Daniel D. Maki, MD: A Very Good Month for Breast MRI

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March initiated what could be a sea change in the diagnosis of breast cancer in high-risk women, with results of a breast MR study published in the New England Journal of Medicine and, in the same week, new guidelines issued from the American Cancer Society (ACS) that recommended breast MR as a screening tool for high-risk women. The breast MRI trial, conducted by the American College of Radiology Imaging Network (ACRIN) and financed by the National Institutes of Health, evaluated the effectiveness of using breast MRI of the contralateral breast in 969 women with recently diagnosed breast cancer. MRI detected clinically and mammographically occult breast cancer in the contralateral breast in 30 of 969 women who were enrolled in the study (3.1%). All participants underwent dynamic contrast-enhanced breast MRI on a 1.5T or greater magnet. Biopsy was performed in 121 of the 969 women (12.5%), and 30 of the specimens were positive for cancer (24.8%); 18 of the 30 specimens were positive for invasive cancer. The mean diameter of the invasive tumors detected was 10.9 mm. Participating imaging sites included both academic institutions and private practices. ImagingBiz.com recently spoke with one of the study’s 13 co-authors, Daniel D. Maki, MD, representing the 42-physician practice Scottsdale Medical Imaging Ltd, Scottsdale, Ariz. Maki, fellowship trained in MRI and thoracic imaging and ACRIN Trial 6667 coordinator for SMIL, discussed the implications of both the study and the new ACS guidelines for patients and the imaging center business. He also commented on the value of private practice participation in ACRIN studies. ImagingBiz.com: What are the implications of the study for patients? MAKI: The implication of the study is that breast MR is extremely sensitive for the detection of cancers in the opposite breast in patients who have been diagnosed with breast cancer. It showed a large increased yield in detection of cancers over mammography and physical exam alone. Traditionally, about 3% of those patients diagnosed with breast cancer in one breast were found to have cancers in the opposite breast coincidentally with physical exam and mammography. Well, breast MRI finds an additional 3.1% so it’s about a 100% increased yield in the cancer detection over physical exam and mammography, which is pretty significant. ImagingBiz.com: What does this imply for imaging centers? MAKI: The implication for imaging centers is that there is the potential for a lot more breast MR to be performed. In this study, we primarily looked at imaging of the opposite breast, but one could infer from the results that breast MRI is extremely sensitive and accurate and can be used in the cancer breast as well, which is already being done in many places around the country, including at SMIL. When you look at both accurately staging the initial tumor as well as staging the opposite breast, I think the potential is for a large increase in utilization of breast MR over the next few years. In an ancillary note, the American Cancer Society came out with the new guidelines that recommend breast MR annually as a screening tool in patients who are very high-risk for breast cancer. And that made big news nationally, as well, and that will also increase utilization. These are patients who don’t even have the cancer, these are patients who carry the genes or have very strong family history. In these patients it will be used potentially as a screening tool. ImagingBiz.com: Are there any special technical challenges in performing breast MRI? MAKI: Several things. Number one, breast MR is not like doing an MR of the knee or shoulder in that you can put somebody in and even if you don’t do a perfect job, you’ll get a diagnostic study. To the contrary, there are some very strict guidelines to be followed. You have to have contrast and the scans have to be performed at certain intervals following contrast, and if your time intervals are off or your injections are off, it will be a non-diagnostic study. In addition, it needs to be performed on a specialized breast coil in order to get really high-resolution images, it can’t just be done in a body coil. There are some well-published guidelines on how to do them correctly, and we also described our protocol in the study. Places that try to do breast MR haphazardly, not injecting the contrast dynamically, not performing the scans at the appropriate time intervals, and not using the high resolution specialized breast coil, are not going to get studies that are diagnostic and useful. ImagingBiz.com: Which referrers will be targeted in your marketing? MAKI: As part of the study, we have built up a large referring base of breast surgeons who sent a large number of breast MRs to us over the last 4 to 7 years. They send us all of their work, and we provide them with a high level of service. That’s probably not going to be built upon a huge amount. Where the potential is for us is with primary care, particularly with the new guidelines for high-risk patients. A lot of women out there have strong family histories. There are women walking around out there with the BRCA gene, and those patients will probably be sent to us for screening with the new ACS guidelines. Where we can really build is in working with the primary care physician to make sure they understand these new recommendations. ImagingBiz.com: What message will you take to the marketplace? MAKI: We are going to make sure that everyone understands the guidelines. We have quarterly newsletters that go out to physicians that talk about new imaging guidelines and new imaging recommendations and innovations, so we will make sure it goes out in the newsletter, and we may send out a copy of the ACS guidelines with it. But a lot of the information that we try to get out to referring physicians is done on a one-to-one basis. In the hospital, we have weekly outings with our marketing team: one doc will go to doctors offices with our marketers and meet one-on-one to go over new recommendations and new pieces of literature that are applicable to their practice. I think a lot of it will be through one-on-one, doctor-to-doctor, discussions rather than sending lots of mailings. It’s just not the way we typically do that. But rather than emphasize the breast MR study to grow our breast MR business, which is already very strong, I think the angle we are going to take is to use it as an example of the innovation, subspecialty expertise, and dedication to service that we have throughout our practice, and this is another example of that for our referrers and our patients. We are always trying to let our referrers know that we have a big research department, we are on the leading edge of technology, research, and new techniques, and we participate in building national recommendations. We are also involved in national CT colonography trials, national vertebroplasty research, and in chemoembolization of liver and tumor trials. This is just another example of where SMIL is dedicated to subspecialty expertise and cutting edge new technology research, so that is the message we want to get out. ImaginBiz.com: How will you address the high incidence of false positives? MAKI: There was about a 9% false biopsy rate, which, if you consider the patient population involved and the risk nature of these patients, a 9% risk of a negative biopsy versus a potential 100% increased yield in contralateral cancer detection is a pretty good trade off. Everything in medicine is risk versus benefit. That’s the message to convey to people who ask about the false positives, because there are false positives in every sort of breast imaging and every sort of breast workup. Mammography has false positive biopsies, ultrasound does, as does physician exam. There are a fair number of patients who have a palpable lump but have nothing on mammogram, nothing on ultrasound, and have an exisional biopsy and it is negative. Every sort of breast workup has false positives and 9% in a very high risk, select population with the trade-off of 100% increased cancer yield I think is a pretty reasonable trade off. ImagingBiz.com: Will you make a special effort to market to patients? MAKI: We feel that the news has, for the most part, already reached a lot of patients and it was all over the today show and the national news and the morning shows, and I did interviews on the local news and with local radio, and the front page of the Arizona Republic newspaper. We feel a lot of the news is already out to the patients, but I think we will also have some literature in waiting rooms for patients who are diagnosed with breast cancer that will discuss potential further staging workup with breast MRI. It won’t be given to every person getting a screening mammogram, but to patients who are recently diagnosed with cancer, to give them additional options for workup. ImagingBiz.com: Is the reimbursement there? Should imaging centers expect difficulties in getting paid? MAKI: We’ve found in our area, most of our third-party payors are paying now for MRI when it’s for a diagnostic workup. For instance, someone has been diagnosed with cancer and they want to accurately stage the cancer: they typically pay for that. If someone has a palpable lump that isn’t seen on mammogram, they typically will pay for that. There is a variety of applications that they typically pay for now. The one thing they haven’t paid for to date is the screening MRI, and with the new ACS guidelines suggesting screening MRI for these high risk BRCA and other family history patients, that may be something that changes with time. It’s hard to say what the third-party payors are going to do with regard to screening. It certainly is never going to be paid for as a screening tool for the general public, but for the select high-risk population, the guidelines are suggesting it now, so the pressure is going to be on the third-party payors. There are going to be patients and potentially politicians and others who are going to be writing letters advocating this. ImagingBiz.com: Historically, participation in research was limited to academic sites. What value does SMIL get from participating in the ACRIN and vice versa? MAKI: Our participation says a lot. It says a lot about our operation, our company. First of all, the fact that we were invited to participate in the trial that was predominately large, tertiary-care academic centers, says a lot about us individually. And we were one of a very few private practices and, actually, I think, the third largest contributor of patients in the whole trial. In terms of the bigger picture, a lot of these large trials need to consider inviting and involving upper-echelon, private practices simply because they are more efficient, and they can potentially, more readily recruit patients than some of these larger academic centers that have a bigger bureaucracy, more red tape, and a lot of other hindrances. Traditionally, all of these trials have gone through academic centers and there is a lot to be said for that. But there is something to be said for involving some very good, larger, well-recognized efficient private practices simply because they do a large number of patients, they are very efficient, they are very well run, and they don’t have all of the red tape you have with large tertiary care centers.