Tuesday, November 21, 2023

Cohort Study (Part 1)- Dense Breast Scanning Survey / Molloy University


Transcript by: Noelle Cutter, Ph.D.
Edited by: Roberta Kline, MD and Lennard M. Goetze, Ed.D

We started working with the Terason 3200t Ultrasound (hereinafter shall be referred to as the Terason) in the summer of 2022. The goal of the project was to be able to scan a limited number of younger premenopausal women under the age of 40 who are more likely to have dense breasts based on their status as being endurance based athletes. We have been exclusively using the Terason based on the recommendation of our lead radiologist Dr. Robert Bard.  The Terason became our lab scanner of choice to conduct the screening of 10 individuals in the lab on a voluntary basis to get a readout for their breast density. Endurance athletes are more prone to dense breast tissue, especially athletes under the age of 40. Mammographic density is the strongest risk factor for non-familial breast cancer among women, especially those under the age of 40.   Metastasis, tumor relapse, and resistance to therapy remain the principal causes of death for breast cancer patients and the lack of effective therapies calls for an improved understanding of the molecular mechanisms driving breast cancer progression. Early identification of mammographic density is an essential step in preventative health.

The Dense Breast paradigm continues to plague our population of the underdiagnosed and underserved women. uniting with public advocates and legislative change makers like the ARE YOU DENSE? FOUNDATION raises significant public awareness in both the clinical and patient communities (see news feature).  Meanwhile, this cohort study received great support from the medical research and diagnostic society whereby scientific leaders like Dr. Robert L. Bard (diagnostic imaging specialist) and Dr. Roberta Kline (epigenetics expert in women's health) helped to spearhead their own respective areas of study to help offer new insight and data in support of the launch of this field research program.

We assembled 10 volunteers for our initial review. These subjects were all selected from the triathlete community who recently either participated in the full distance 140.6 Ironman or the half distance 70.3 Ironman in 2022.  From Molloy University (base 1 of our research), I recruited from our student population who also worked in the lab- as well as from my professional contacts in the endurance world. 

To note, out of our select volunteers, three have been clinically diagnosed with breast cancer within the last five years. I would say that out of the two women who had cancer, both had dense breasts, and both were Ironman athletes under the age of 40 when they were diagnosed. They're both over the age of 40 now. So, they knew that already going into our scanning. I am glad to also report that both cases remain in remission.  Noting these cases, we did not consider using them as a control by any means, only that this is part of the data that we are collecting as additional considerations that relate to our survey for tissue density, as a means of comparison. 

The other eight subjects were young women all under the age of 35- and none of them had any idea about breast density. They've never had any breast screenings in their life besides self-breast examinations- hence, they had no idea about density. Furthermore, they had no idea of how mammographic density is really one of the strongest risk factors for non-familial breast cancer among women and especially among younger women. Undergoing our 'simple' screening session gave them the beginnings of a sense of personal ownership and advocacy about their health.  Perhaps this experience (for them) could lead to proactive steps that they need to take- the next time they visit with either their OBGYN or their general physician. They now have an idea about the types of tests to request to be proactive about their health They also have some clarity about mammographic density in their breasts. 

My technicians and I found the Terason to be "super portable" and upon scanning our first few subjects, we immediately understood why Dr. Bard suggested this brand and model. The picture quality and imaging system is very clear and the user interface is very easy to read. For someone who is not experienced or well trained in using an ultrasound, with one or two training sessions I was able to easily use the machine to work with our volunteer subjects. 

An underlying test is the feasibility of using the Terason itself in actual field work. The portability is astounding (to me). This means we can pack it up. I don't even need any sort of a car. I could throw it on my back and get on a bicycle and bring it to a, uh, a destination.  As far as its' performance, my group and I did our own homework about its accuracy and reliability and what we often found was the common statement about it being "battle-tested"- in the EMS world). Targeting the triathlete community, all these features are critical advantages to roadside screening! It's easy to use and even easier to train other research assistants in the lab to use it. And with Dr. Bard (and his expert interpretation) on the receiving end of our scans, that is the ultimate peace of mind and a COMPLETE tele-health scanning paradigm. 

To note, our research concept focused on using the ultrasound because it is completely safe and effective at scanning for (something like) image breast density. Particularly for our research, it's portable in the field, so we can bring it to the race locations. I can bring it into the lab, I can bring it into my office. I can really package it up in a small briefcase sized bag, and it can come with me and travel with me anywhere I need to go. 

Working with Mike (Terason virtual trainer) was surprisingly easy, and he thoroughly guided me over the phone and via the device itself which is also a computer. He gave us such a comprehensive tour on all of the different probes but of course, we were focused on the one (L20) probe that was suited for of screening of breast density.  We found the device itself to cover the most common demands of a hospital-grade or field-grade ultrasound including the ability to capture measurements of critical data like blood flow and density. Recalling my initial training session with Dr. Bard (at his office) aligned with everything because as a field/remote ultrasound tech, I am literally capturing all images for him (our in-house radiologist).  This Terason model truly enables this remote scanning paradigm between the field screening tech in communication with the central radiologist- making for a truly ideal and real time professional collaboration!   (To be continued below)

Epigenetic Research Notes: Profiling the Dense Breast Paradigm
A Clinical Report by: Dr. Roberta Kline

As an Ob-Gyn physician and genomics specialist, I have spent the better part of 10 years translating research in the genomic and gene expression areas into clinically usable information for healthcare professionals. One of the biggest challenges we face when connecting research with patient care is the long delay in the translation process and dissemination of the information. It often takes 10 to 20 years for information (validated findings) that comes out of research to be applied in clinical practice. These delays result in many lost opportunities to provide better care for our patients. This is one of the reasons why I'm really passionate about accelerating this process and making it easier for clinicians and their patients to take advantage of cutting-edge information and new technologies. 

I believe that because our focus was on women with dense breasts and the fact that this issue is now showing escalating rates, the urgency for this project also aligns with an increased likelihood of developing cancer within their lifetime. We also know that women, especially pre-menopausal women, are often not sent for imaging unless they have a family history. But we know only about five to 10% of breast cancers occur because of an inherited or genetic variant. So the likelihood that we're missing a lot of women (especially young women) who may have an early stage of breast cancer is the big concern. 

This project was developed out of the need for a safe, effective, and affordable screening alternative. We wanted to explore and possibly attest to the higher benefits of this modern (and field-friendly) alternative vs. the existing "gold standards" which are far more inaccessible, expensive and potentially invasive- as far contrast or radiation. I appreciate my understanding of ultrasound as a fully safe and effective imaging modality - and one that we can use and easily can be accessed in any physician's office or anywhere else. 

After our dedicated training course, the roll-out to being a stage 1 ultrasound technician was very comfortable and truly supportive of our goals about ultrasound as the path to the future and "the better way".

As far as goals, our main objectives are (of course) advocacy and to identify women younger using a more safe and effective screening method. Another goal that we found of great interest in enabling ACCESS to women have dense breasts; we wanted to explore ways that we can get them screened sooner. We can have them checked out to make sure that there are no early cancers that are being missed through other tools and techniques that we can use. In addition to this, we can start looking at how density correlates to cancer. Our early studies indicate that many of the pathways enriched in patients with higher mammographic density are targetable, raising the possibility of developing prevention strategies for mitigating density-associated breast cancer risk. We hope to further elucidate those molecular changes and those genetic signatures that may be common in women with dense breasts. Our overall goal is to increase survivability and offer targetable outcomes for the patient. 

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