Removal Of Nonpalpable Breast Lesions Research Articles

Cutting Healthcare Costs with Hematoma-Directed Ultrasound-Guided Breast Lumpectomy.

Localization of nonpalpable breast lesions for breast-conserving surgery (BCS) remains highly variable and includes needle/wire localization (NL), radioactive seed localization, radar localization, and hematoma-directed ultrasound-guided (HUG) lumpectomy. The superiority of HUG lumpectomy over NL has been demonstrated repeatedly in terms of safety, accuracy, low positive margin rates, cosmesis, and patient satisfaction. In this study, we evaluate the cost effectiveness of HUG lumpectomy over NL for nonpalpable breast lesions. We performed a retrospective review of 569 patients who underwent lumpectomy at the University of Arkansas for Medical Sciences from May 2014 through December 2017. Lumpectomies were stratified by localization technique, i.e. NL versus HUG. A cost-savings estimate was determined for the HUG localization technique, and a total amount of dollars saved over the study period was calculated. Overall, 569 lumpectomies were performed: 501 (88.0%) via HUG and 68 (12.0%) via NL. Intraoperative ultrasound was used in 566 operations (99.5%). Of the lumpectomies performed by HUG, 190 lesions (33.4%) were visible only on mammogram or breast magnetic resonance imaging prior to diagnostic core needle biopsy (CNB). Cost estimates comparing HUG with NL demonstrated a cost savings of $497.00 per procedure, the cost of preoperative needle localization by a radiologist, and a total of $94,430.00 for the study period. In utilizing HUG lumpectomy, the initial CNB serves as the diagnostic and localization procedure, thus saving time and a painful second procedure on the day of operation. HUG lumpectomy is safe, accurate, reduces healthcare costs, and results in a better patient experience for the surgical removal of nonpalpable breast lesions.

Abstract P3-13-08: A prospective, single-arm, multi-site, clinical evaluation of the SAVI SCOUT® surgical guidance system for the location of non-palpable breast lesions during excision

Abstract Background and Objectives: The standard preoperative technique for localizing non-palpable breast lesions is wire localization (WL). Radioactive seed localization (RSL) is an alternative approach that addresses a number of clear disadvantages associated with WL but, the adoption of RSL has been impacted by considerable regulatory requirements for the handling of radioactive materials. To advance the progress made with RSL and eliminate issues associated with radioactive components, the SAVI SCOUT® surgical guidance system was developed. SAVI SCOUT is an FDA-cleared medical device that utilizes non-radioactive electromagnetic wave technology to provide real-time guidance during excisional breast procedures. The purpose of this study is to evaluate the performance of SAVI SCOUT in guiding the removal of non-palpable breast lesions. Methods: Following a 50 patient pilot study that showed SAVI SCOUT to be safe and effective, IRB approval was granted for this prospective, single-arm, multi-site study for women with a non-palpable breast lesion. Pts underwent localization and excision with the SAVI SCOUT system, which consists of an electromagnetic wave reflective device (reflector), handpiece and console. Using mammographic or ultrasound guidance, the reflector was implanted into the target tissue. Before making an incision, the surgeon used the handpiece, which emits electromagnetic waves and infrared light, to detect the location of the reflector and subsequently plan the surgical incision. During the procedure, the surgeon used the handpiece to guide the localization and removal of the reflector along with the surrounding breast tissue. The console provides audible feedback of reflector proximity to the handpiece. Successful reflector placement, localization and retrieval were the primary endpoints. Results: A total of 61 pts have participated in the study to date, along with 7 surgeons and 9 radiologists across 6 institutions. The reflectors were successfully placed in all pts, including 27 under mammographic guidance and 34 under ultrasound guidance. In 28 cases, the reflectors were placed on the same day as surgery. Otherwise, the reflectors were placed up to 7 days (average 2.9 days) before surgery. Thirteen pts underwent excisional biopsy and 48 pts had a lumpectomy. The intended lesion and reflector were successfully removed in all pts. Reflector migration did not occur and no adverse events occurred. Final pathology is currently available for 52 pts: 8/10 excisional biopsy pts had no invasive or in situ carcinoma identified. For pts with cancer and complete data, 39/39 had clear margins, but one patient was recommended for re-excision due to a close margin (1 mm) for DCIS. Conclusions: The preliminary data from this prospective, multi-site study show that real-time surgical guidance with SAVI SCOUT is an accurate technique for directing the removal of non-palpable breast lesions and is reproducible at multiple clinical sites. At present, the study has yielded 100% surgical success with a re-excision rate of 3.0%. Ongoing accrual to this clinical evaluation study will validate these findings with planned enrollment of 150 pts at up to 15 total sites. Citation Format: Cox CE, Prati R, Blumencranz P, Allen K, Banull C, Cline M, Howard T, Portillo M, Whitworth P, Funk K, Police A, Lin E, Combs F, Anglin B, King J, Shivers SC. A prospective, single-arm, multi-site, clinical evaluation of the SAVI SCOUT® surgical guidance system for the location of non-palpable breast lesions during excision. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P3-13-08.

Abstract P1-16-10: Pilot study of a passive non-radioactive electromagnetic wave technology to localize non-palpable breast lesions

Abstract Background and Objectives: The standard preoperative technique for localizing non-palpable breast lesions is wire localization (WL). Radioactive seed localization (RSL) has been described as an alternative approach to address the number of clear disadvantages associated with WL. Yet, despite its proven advantages, the adoption of RSL has been impacted by considerable regulatory requirements for the handling of radioactive materials. To advance the progress made with RSL and eliminate the issues associated with radioactive components, the SAVI Scout® surgical guidance system has been developed. The SAVI Scout surgical guidance system is an FDA-cleared medical device that utilizes passive non-radioactive electromagnetic wave technology to provide real-time guidance during excisional breast procedures. The purpose of this pilot study is to determine the safety and efficacy of the SAVI Scout system in localizing and directing the removal of non-palpable breast lesions during excisional biopsy and lumpectomy procedures. The preliminary results from two institutions are reported. Materials and Methods: Following a feasibility study using the SAVI Scout system in resected breast tissues ex vivo, Institutional Review Board approval was granted for both institutions for women with a non-palpable breast lesion requiring preoperative localization for excision. Participating patients underwent localization and excision with the SAVI Scout system, which consists of an electromagnetic wave reflective device (reflector), handpiece and console. Using mammographic or ultrasound guidance, the reflector was placed percutaneously up to 7 days prior to the scheduled excisional procedure. At surgical excision, the surgeon used the SAVI Scout handpiece to locate the reflector, which was removed along with the surrounding breast tissue. The console provides audible feedback of reflector proximity to the handpiece. Successful reflector placement, localization and retrieval were the primary endpoints. Results: After the first training case (data not used), a total of 17 patients have participated in the study to date. The reflectors were successfully placed with mammographic guidance in 9/9 patients and with ultrasound guidance in 8/8 patients. Reflectors were placed an average of 1.7 days (range 0-6 days) before surgery. Five patients underwent excisional biopsy and 12 patients had a lumpectomy. The intended lesion and reflector were successfully removed in 17/17 patients. Reflector migration did not occur and no adverse events occurred. Of the 14 patients in which final pathology is currently available, 6 patients had no invasive or in situ carcinoma identified, 4 had no tumor in the excision, and 3/4 patients with tumor had clear margins. One patient had a focally positive margin and was recommended for re-excision. Conclusions: The preliminary data show the SAVI Scout system to be a safe and effective tool for the localization of non-palpable breast lesions. Ongoing accrual to this pilot study will validate these findings with planned enrollment of a total of additional 50 patients in the next 60 days at up to 3 additional sites. Citation Format: Charles E Cox, Melissa Themar-Geck, Ronald Prati, Michelle Jung, Jeff King, Steven C Shivers. Pilot study of a passive non-radioactive electromagnetic wave technology to localize non-palpable breast lesions [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-16-10.

Development of sentinel node localization and ROLL in breast cancer in Europe

The concept of a precise region in which to find the lymph nodes that drain the lymph directly from the primary tumor site can be traced back to a century ago to the observations of Jamieson and Dobson who described how cancer cells spread from cancer of the stomach in a single lymph node, which they called the “primary gland”. However, Cabanas was the first in 1977 to realize the importance of this concept in clinical studies following lymphography performed in patients with penile cancer. Thanks to Morton’s studies on melanoma in 1992, we began to understand the potential impact of the sentinel lymph node (SN) on the surgical treatment of this type of cancer. The use of a vital dye (blue dye) administered subdermally in the region surrounding the melanoma lesion led to the identification of the sentinel node, and the vital dye technique was subsequently applied to other types of solid tumors, e.g. breast, vulva. However, difficulties in using this technique in anatomical regions with deep lymphatic vessels, e.g. axilla, led to the development of lymphoscintigraphy, started by Alex and Krag in 1993 on melanoma and breast cancer and optimized by our group at European Institute of Oncology (IEO) in Milan in 1996. Today, lymphoscintigraphy is still considered as the most reliable method for the detection of the SN. In 1996, a new method for the localization of non-palpable breast lesion called radioguided occult lesion localization (ROLL) was also developed at IEO. Retrospective and prospective studies have since shown that the ROLL procedure permits the easy and accurate surgical removal of non-palpable breast lesions, overcoming the limitations of previous techniques such as the wire-guided localization. The purpose of this paper is to describe the evolution of SN biopsy and radioguided surgery in the management of breast cancer. We also include a review of the literature on the clinical scenarios in which SN biopsy in breast cancer is currently used, with particular reference to controversies and future prospects.

Ex Vivo MRI Evaluation of Breast Tumors: A Novel Tool for Verifying Resection of Nonpalpable Only MRI Detected Lesions

A fundamental question in surgery of only magnetic resonance imaging (MRI)-detected breast lesions is to ensure their removal when they are not palpable by clinical examination and surgical exploration. This is especially relevant in the case of small tumors, carcinoma in situ or lobular carcinoma. Thirty-nine patients were enrolled in the study, 21 patients with breast lesions detected by both conventional imaging and breast MRI (bMRI) and 18 patients with bMRI findings only. Preoperative bMRI allowed staging the disease and localizing the lesion. In the operating theater, contrast medium was injected 1 minute before skin incision. After removal, surgical specimens were submitted to ex vivo MRI, performed using a dedicated surface coil and Spair inversion recovery sequences for suppression of fat signal intensity. All MRI enhancing lesions were completely included within the surgical specimen and visualized by ex vivo MRI. In the first 21 patients, bMRI was able to visualize branching margins or satellite nodules around the core lesion, and allowed for better staging of the surrounding in situ carcinoma; in the last 18 patients, eight of whom were breast cancer type 1 susceptibility protein (BRCA) mutation carriers, bMRI identified 12 malignant tumors, otherwise undetectable, that were all visualized by ex vivo MRI. This is the first description of a procedure that re-enhances breast lesions within a surgical specimen, demonstrating the surgical removal of nonpalpable breast lesions diagnosed only with bMRI. This new strategy reproduces the morphology and the entire extension of the primary lesion on the specimen, with potentially better local surgical control, reducing additional unplanned surgery.

Accurate excision of nonpalpable breast lesions with the new device system.

e11557 Background: A histological diagnosis for nonpalpable breast lesions (NPBL) is required to determine suitable therapy. The open-breast biopsy (OBB) is the gold standard to determine the nature of NPBL. However, it is not easy to accurately remove whole breast lesions due to insufficient safe margin of lesions excised. To improve accuracy for removal of NPBL, we designed new tools to assist surgeons to accurately localize and remove NPBL during OBB. Methods: The new device system has two primary parts. First is a set of accurate-resection devices composed of a rotary cutter, a pair of inner and outer tubes, two pairs of concave and convex curved hooks, and a curved incision plate. The second part is the 12 o'clock localization method used to accurately position lesions three-dimensionally after the breast tissue is excised cylindrically. Thus, the exact location of breast lesions removed can be precisely traced back to the original breast tissue location. Results: 100 patients with a total of 149 OBB were studied using the new device system guided with needle localization under ultrasound. 112 out of 149 procedures were identified as nodule. Among 112 cases, 95 were breast fibroadenomas, 10 were mammary adenosis with a trend to form fibroadenoma, 5 were mammary adenosis, and 2 were adipomas. The remaining 37 cases possessed clusters of calcified lesions with small nodule. 32 were benign lesions with calcinosis, and the other 5 lesions were identified as breast cancer. Pathological examination demonstrated that 144 NPBL were accurately resected with accurate-resection devices. However, 19 out of 144 breast lesions were not completely removed the first time. Thus the second surgical procedure was performed for the 19 cases based on 12 o'clock localization method. The results demonstrated that the remaining lesions were accurately and completely eliminated with the second procedure. All patients were followed up with for 2 to 48 months post procedures. These patients treated with accurate resection devices were very satisfied with no breast deformation. Conclusions: The new device system is easy to use and has very low cost. It is very comfortable for the patient and is of great help in accurately localizing and resecting the lesions to the surgeon.

A novel approach to identify non-palpable breast lesions combining fluorescent liposomes and magnetic resonance-guided high intensity focused ultrasound-triggered release

The combination of fluorescein-containing liposomes (FCL) and magnetic resonance-guided high intensity focused ultrasound (MR-HIFU)-triggered release is a promising approach for lesion demarcation and more efficient removal of non-palpable breast lesions. Exposure of FCL to ablation temperatures (60°C) using MR-HIFU would result in palpable, stained tumors, which are more easy to identify during surgical resection. In this study, proof-of-concept concerning fluorescent FCL for MR-HIFU-triggered release and tumor demarcation of non-palpable breast lesions is presented. Ex vivo experiments in human blood and porcine muscle tissue showed increased label release from the liposomes, clear fluorescence enhancement and diffusion of the released compound after heating to 60°C. Next, fluorescein release of FCL was observed after MR-HIFU-mediated mild hyperthermia (42°C) and ablation temperature (60°C) for a short period (30s), which is in line with the clinically relevant MR-HIFU treatment parameters. These results indicate the potential of the FCL as a tool to improve tumor demarcation in patients by MR-HIFU-triggered release. Therefore, this method may offer a new tool for efficient surgical resection of non-palpable breast tumor lesions by enabling proper discrimination between tumor tissue and adjacent healthy tissue.

Detecção e exérese de lesões mamárias não palpáveis orientadas por cirurgia radioguiada com injeção de ar para controle radiológico

OBJETIVO: avaliar a eficiência da localização e exérese por cirurgia radioguiada de lesões ocultas mamárias utilizando radiofármaco injetado diretamente no interior das lesões ou até dois centímetros destas com posterior injeção de ar como controle radiológico. MÉTODOS: vinte e nove pacientes com 32 lesões mamárias ocultas, detectadas por mamografia ou ultra-sonografia, classificadas como Bi-Rads® 3, 4 e 5 foram incluídas neste estudo observacional com resultados expressos em percentagens. O radiofármaco utilizado foi o macroagregado de albumina marcado com tecnécio-99m (99mTc-MAA) injetado por orientação mamográfica ou guiado por ultra-sonografia. A injeção do radiofármaco foi seguida pela imediata administração de ar, através da agulha da estereotaxia, visando o controle radiológico da injeção do radiofármaco. A biopsia excisional foi feita com o auxílio do aparelho portátil gamma-probe (detector de radiação gama) e a remoção completa das lesões foi verificada pela radiografia das peças cirúrgicas ou por exame por congelação intra-operatório. RESULTADOS: câncer de mama foi encontrado em 10% (1/10) das lesões BI-RADS® 3, em 31,5% (6/19) das BI-RADS® 4 e em 66,6% (2/3) das BI-RADS® 5. As 29 pacientes corresponderam a 32 espécimes, cirúrgicos. O radiofármaco foi corretamente posicionado em 96,8% (31/32) dos espécimes permitindo remoção de 96,8% das lesões mamárias não palpáveis estudadas. A completa remoção da lesão foi demonstrada pela radiografia das peças em 23 casos (71,8%), pelo estudo intra-operatório por congelação em 21,8% (7/32) e por ambos os métodos em 6,2% (2/32). CONCLUSÃO: a cirurgia radioguiada é importante instrumento na remoção de lesões mamárias não palpáveis, tratando-se de método simples, rápido e exeqüível que pode ser implementado na rotina clínica dessas pacientes.

Hematoma-directed ultrasound-guided breast biopsy.

The standard technique for removal of nonpalpable breast lesions is needle localization breast biopsy. Because traumatic hematomas can often be seen with ultrasound, the authors hypothesized that iatrogenically induced hematomas could be used to guide the excision of nonpalpable lesions using ultrasound. Twenty patients with nonpalpable breast lesions detected by magnetic resonance imaging only were enrolled in this single-institution trial, approved by the institutional review board. A hematoma consisting of 2 to 5 mL of the patient's own blood was injected into the breast to target the nonpalpable lesion. Intraoperative ultrasound of the hematoma was used to direct the excisional biopsy. The average age of women was 53.8 +/- 10 years. Ninety-five percent of lesions detected by magnetic resonance imaging were localized by hematoma injection. All the hematomas used to recognize targeted lesions were identified at surgery by ultrasound and removed without complication. Eight (40%) of the lesions were malignant, with an average tumor size of 12 +/- 6 mm (range 4-25). The remaining 12 lesions (60%) comprised papillomas, sclerosing adenosis, radial scar, fibroadenoma, and areas of atypical ductal hyperplasia. The results of this pilot study show the effectiveness of hematoma-directed ultrasound-guided breast biopsy for nonpalpable lesions seen by magnetic resonance imaging. This new procedure is potentially more comfortable for the patient because no wire or needle is left in the breast. It is technically faster and easier because ultrasound is used to visualize directly the location of the hematoma at surgery and to confirm lesion removal in the operating room by specimen ultrasound. The hematoma can be placed several days before biopsy, easing scheduling, and without fear of the migration that may occur with needle localization. This method may have ready application to mammographically detected lesions.

New Instrumentation Allows for Removal of Nonpalpable Breast Lesions

Breast cancer is the second leading cause of cancer deaths in women. Approximately 90% of breast cancer is curable if it is diagnosed and treated early. Increasingly, women are participating in mammographic screenings, which result in earlier detection of nonpalpable lesions. In the past, surgical removal was not an option for small lesions, and frequent mammographic monitoring was required until patients' lesions were large enough for needle core biopsies or needle localization for open surgical biopsies. Technology now has combined stereotactic imaging with a minimally invasive biopsy system for removal of these nonpalpable lesions. This capability for accurate early diagnosis and intervention is essential in improving patients' survival rates.

Nonpalpable breast lesions: accuracy of prebiopsy mammographic diagnosis.

Mammograms of 220 patients who underwent spot localization for removal of nonpalpable breast lesions were reviewed for accuracy of interpretation. Results of subsequent biopsy indicated malignancy in 77 cases. The interpretations of mammograms obtained before biopsy were incorrect in 71 cases (27 false-negative and 44 false-positive studies). Among the false-negative cases, 70% of the abnormalities were determined histologically to be noninfiltrative cancers. An aggressive screening program with preoperative localization and biopsy is needed in questionable cases, since mammographic signs of early or nonpalpable malignancy are often subtle and nonspecific.