Friday, May 21, 2021

How this MICRO IMPLANT RADAR revolutionized breast cancer surgeries

 INTRODUCTION

For surgical procedures of breast cancer, NYCRANEWS explores wire-free Radar Localization - a pre-surgical procedure to locate and mark the exact breast abnormality through the use of a small, 12×1.6 mm implanted radar reflector device, roughly the size of a grain of rice. This micro-electronic implant communicates with the scanning handpiece, allowing the surgeon to identify the exact tissue (and how much of it) to extract during a lumpectomy [1]. The early process of localization came in the form of a guide wire insert but later advancements offered other solutions including a wireless radioactive seed and (then) a non-radioactive version called SCOUT®- formerly called SAVI-SCOUT (until July, 2019) [2]. It was developed by Cianna Medical and then acquired in 2018 by Merit Medical, an American medical technology company. 

Publishers of FightRecurrence.com and PinkSmart News dedicated a review of this surgical solution in support of improvements in the preservation of the breast during surgery.  In this feature article, we present Dr. TroyShell-Masouras of Paradise Coast Breast Specialists in Naples Fla. - and David Gilstrap, Director & Global Product Management of Merit Medical. Together, we explored technical perspectives and design strategies behind radar localization and the SCOUT® technology.  They shared the procedural advantages provided by the wire-free upgrade as well as its overall improvements to the patient's well-being in the pre and post-surgical phases.

 

WIRE-FREE UPGRADE IN LOCALIZED IMPLANTS
This segment is from Mr. David Gilstrap's 5/2021 interview.

The concept of SCOUT® wire-free radar localization was developed by Cianna Medical in 2010 and was an alternative to the predominant guide wire concept.  The launch of the SCOUT® introduced "going wire free" for the patient, providing a huge impact on patient satisfaction. Prior to this, the original process included placing a wire in the patient the day of  surgery, and the patient maintains this wire sticking out of their breast until surgery time, which could be up to several hours.

The genesis of the non-radioactive reflector came about in 2010 as the company started re-evaluating the breast surgery localization space, because at the time there were only two other options available;  the guide wire solution (standard for 50+ years) and the radioactive seed alternative. Despite its advantages, the radioactive seed solution showed its own set of limitations and regulatory issues, limiting its public acceptance.  "It needed a lot of training and tracking and was restricted to a limited time where you can actually place it."

By December 2014, Cianna Medical received FDA Clearance for the first generation of SCOUT®  allowing full commercialization in the U.S, and CE Mark for Europe would follow. The implant is technically called the reflector. It doesn't transmit a signal, but actually reflects a signal that's being sent to it. It has its own electronic circuitry, an antenna and it is sealed with a bio-compatible coating called APTEK. There's no power source or moving parts in the reflector- it's inert. With FDA long-term implant status, when it's placed into a patient,  there are no limitations on removal and it can remain in the patient forever. It doesn't have to be removed again. There's no risk to the patient or the area of interest.

Once placed into the region for surgery, the surgeon uses the SCOUT®  surgical guide which transmits pulsating infrared light and a pulsating radar signal (at 50 million pulses/sec). This infrared light activates the reflector which bounces the radar signal back to the system, giving an audible cadence when detected as well as distance measurements from the end of that guide, accurate to one millimeter. To simplify, the technology is very similar to the micro power impulse radar used in your backup sensors in automobiles. So it is very accurate in detecting things over very short distances.

Merit attributes their success in tech feature upgrades to collected end user data from the surgical community. Prototypes are underway for a reduced reflector size, advanced image guidance, customized targeting cadence and improved ease of use in installation  Since SCOUT® is approved for soft tissues it is rapidly expanding into other surgical sites such as pulmonary nodules and soft tissue sarcomas.



Dr. Barry Rosen, breast surgeon at Good Sheppard Hospital (Chicago, IL) describes the many advantages of wire-free localization technology in oncoplastic surgery. For the patient, this innovation adds a new level of ease and adaptability over the traditional (pain and stress of) the wired version.



 

 

 

 





FROM THE SURGICAL FIELD
Breast surgeon Dr. Troy Shell-Masouras expands on the benefits of the wire-free (non-radioactive) radar  in comparison to the former solutions like the localization wire and radioactive seed. This segment is excerpted from Dr. Shell-Masouras' direct interview in 5/2021.

Initially, the first breakthrough into a wireless approach was the radioactive seed - technology that was well-known in prostate cancer. These pellets can be placed into the breast in a similar fashion where the SCOUT reflector would be placed. Once installed, you would use a probe that detects the signal of the seeds. The issue here is that because it is radioactive, there are very strict monitoring and nuclear medicine guidelines on this process as far as its retrieval. To describe this a different way, imagine inserting this radioactive seed in a patient before their surgery-- then if that patient gets into a car accident or disappeared in some way, your entire radioactive seed program could be shut down because you have to be able to retrieve that seed.

There are limitations on how long that seed is active and detectable. Because of these issues, products like SCOUT were developed where there are no limitations on the activity of the device. Time is of no concern if your patient grows ill and their procedure is postponed a month or so down the road. There's no urgency to retrieve the product at any time. These real-life situations are really why products like this are developed.

Comparatively speaking, there appears to be no difference in accuracy between the wired solution, the radioactive seed and the SCOUT. The radioactive seed is significantly smaller than the SCOUT  but this size difference is a non-issue to surgeons. Statements about SCOUT’s (minor) limitations however mention a slight adjustment in work parameters around the distance between the skin and the device particularly with large breasts or very dense breasts. The SCOUT technology is something that continues to evolve... they are trying to develop where you have a different signal if you have more than one lesion from multiple markers within the breast. Merit is also leading to a lot of competition because everybody wants a piece of that wire free action- but the SCOUT developers set the bar pretty high and a lot of institutions have embraced it... I think it's going to be tough for them to break in since SCOUT has already made their mark.

It is noted that programs using radioactive seeds continue to exist, but the market appears to reflect a transition to non-radioactive devices for reasons described.

Dr. TroyShell-Masouras conducts life saving Breast Cancer Surgery at Paradise Coast Breast Specialists in Naples Fla.  Dr. Shell-Masouras specializes in the diagnosis and treatment of breast cancer and benign breast disease, and provides high risk breast cancer assessments, breast ultrasounds, ultrasound-guided breast procedures to include biopsies and aspiration, partial mastectomy and lumpectomy, total mastectomy to include Hidden Scar™ Breast Conserving Surgery and Hidden Scar™ Nipple Sparing Mastectomy, sentinel lymph node biopsy, axillary lymph node dissection, and radar localization for lumpectomies.


VIEWPOINTS

STEPHEN A. CHAGARES, MD FACS- Cancer Surgeon/ General,Laparoscopic, Robotic Surgery -  Yes, the Scout technology is a great progression of technology. It allows accurate localization with site of incision at the Surgeon’s discretion allowing for significantly increased cosmetic appearance of a lumpectomy. Also, it’s placed days earlier so no radiology delays on OR days waiting for patients to return after being sent down for guidewire placement." 

* Opinions expressed in this VIEWPOINTS section are supportive comments about the contents of this article and are solely those from the contributors credited.









The Male Breast Cancer Coalition presented the work of  Dr. Jose Pablo Leone, medical oncologist and researcher at the Dana-Farber Cancer Institute about his research plans covering tamoxifen and aromatase inhibitors for the treatment of male breast cancer.  While women have the benefits of switching to AI should they contract side effects from Tamoxifen, men are in a harder situation when making this decision because not enough data about the efficacy of aromatase inhibitors (AI) are available for men. 

"Currently, only retrospective studies are available out there, which are prone to selection bias. We need to do more research to get scientific validity to dictate treatment for patients.   Due to the physiological differences in the endocrine system between men and women, there may be differences in the efficacy of aromatase inhibitors, leaving men with only Tamoxifen as their primary option.  Tamoxifen for men is the standard recommended drug for men with metastatic breast cancer. If there is progression of disease after Tamoxifen, then other endocrine therapies can be used in the metastatic setting. This is why we need prospective studies evaluating AI in men."  (See complete article)    



BREAST CANCERSCAN NEWS: From the International Oncology Community (Comunit√† Oncologica Internazionale)

4/30/2021 Dr. Robert Bard has been elected as the Sr. Medical Advisor of the Integrative Cancer Resource Alliance- an international community of diagnostic imaging specialists.  His educational presentation has been translated in over 5 different languages for the world stage, supporting partners in The Netherlands, Italy, France and Germany.  This 2021 report recognizes the advancements in non-invasive, real-time diagnostic imaging of cancer tumors for tracking, monitoring, screening and dual diagnosing as well as preop and image guiding intervention during procedures.  Dr. Bard identifies the global movement and demand for virtualization- a medical innovation for remote multi-disciplinary collaboration (ie, TeleRad, Tele-Health and Virtual Conferences) to support the expansion of data sharing  as a modern paradigm of problem-solving in cancer care. 

In an earlier feature, Dr. Bard celebrates the global solidarity of cancer imaging scientists including the work of some of his most respected research colleagues including Professors Luigi Solbiati, Carlo Martinoli, Rodolfo Campani. These are just some of the many highly regarded members of the pioneering community who helped pave the movement for a much improved detection of cancer tumors and other subdermal disorders. 

(Image-L) Once you have a vascular map of the cancer, we have the initial vessel density of 4.5%. Successful treatment over weeks or months will bring it down. In this case, it's down to one quarter of the initial treatment so this is treatment success. This is quantitative mapping of treatment follow-up because if it's working, it's better to change treatment, to avoid the side effects of chemo or other immunotherapies.  The first circle on top shows the red tumor vessels. The 4D Instagram computer reconstruction gives you a quantitative measure of how many tumor vessels are present. Once you have a number, you can follow the number up or down to verify treatment success or failure to adequately adjust treatment that's needed up or down. (For complete review of CLINICAL IMAGING OF BREAST CANCER Explained, visit: breastcancernyc.com)


GET CHECKED NOW! : EARLY DETECTION SAVES LIVES

According to the 
World Health Organization, early detection of cancer greatly increases the chances for successful treatment. In the ongoing battle against cancer, it is common knowledge that most cancers in their early stages are far more likely to be treated with positive results. Moreover, a thorough checkup of one's physiological analyses, heredity review and personal data gathering are all strong info-gatherings for early warning signs that someone may be a candidate for cancer. PROACTIVE tasking starts from AWARENESS, EDUCATION & REGULAR SCREENINGS. The right attitude of self-preservation and an appreciation for longevity is lesson #1. Pursuing a balanced lifestyle covering all the bases of nutrition, exercise, sleep, detoxing and de-stressing is also part of an overall plan for better quality of life. Also visit: www.FightRecurrence.com

 


References:

1) "What is Breast Needle Localization?"  https://myhealth.alberta.ca/Alberta/Pages/Breast-needle-localization.aspx#:~:text=Needle%20localization%20(also%20called%20wire,by%20mammogram%20or%20ultrasound%20guidance.

2) July 2019: "Exciting Changes are Here for SCOUT Radar Localization: Merit medical is excited to announce that SAVI SCOUT will now be known as SCOUT radar localization...  ": https://www.merit.com/wp-content/uploads/2020/07/SCOUT-Report-2019-July-Changes-for-SCOUT-Radar-Localization.pdf

3) Savi Scout- a Surgeon's Perspective (SAVI SCOUT News/ CiannaMedical Newsletter)- https://www.merit.com/wp-content/uploads/2020/09/201808-SCOUTReport-ASurgeonsPerspective.pdf

4) Introducing the New SCOUT Ultrasound Delivery System (SAVI SCOUT News/ CiannaMedical Newsletter)-: https://www.merit.com/wp-content/uploads/2020/09/201812-SCOUTReport-IntroducingTheNewSCOUTUltrasoundDeliverySystem.pdf

5) Seasoned Leader Appointed to Guide / Merit’s Cianna Medical Franchise (SCOUT REPORT-News) https://www.merit.com/wp-content/uploads/2020/07/SCOUT-Report-2019-February-Seasoned-Leader-Appointed-to-Guide.pdf


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DENSE BREAST DETECTION & IMAGE GUIDED ONCOLOGIC TREATMENT

By: Robert L. Bard, MD & Noelle Cutter, PhD   |  Edited by: Lennard M. Gettz, Ed.D PROLOGUE In 2014, Imaging Technology News (ITN) intro...