Localization Of Nonpalpable Breast Lesions Research Articles

Abstract P4-13-11: A new simplified cost-effective technique for localization of non-palpable breast lesions

Abstract Introduction: Standard wire localization has long been the standard of care to assist surgeons with locating and excising non-palpable breast lesions identified by imaging. Significant challenges include scheduling conflicts, delays in surgery, accuracy in targeting the lesion, wire displacement or migration, and overall inconvenience for patients, clinicians and facilities. In an attempt to address these challenges, a number of complex wireless approaches have emerged. However, they are costly and require the purchase of multiple pieces of capital equipment. Additionally, these wireless approaches lose the benefits of visual and tactile cues for the surgeon during excision. In this multi-centered pilot series, we report on a novel method of percutaneous localization that secures the target lesion, may be placed prior to the day of surgery and provides the surgeon with tactile guidance during dissection without the challenges of standard wire localization. Methods: Following informed consent, 37 patients undergoing partial mastectomy or excisional biopsy were evaluated in a prospective manner. The localization device (PERL™ Hologic, Sunnyvale, CA) consists of a needle cannula with a handle deployment mechanism housing a sharp nitinol Ring. Following infiltration of local anesthetic in the skin and target region, the introducing needle was advanced into the breast under image guidance and the Ring was deployed and securely seated at or around the target. The Ring is attached to a highly flexible, suture-like tail emerging from the skin. When the Ring device was placed the day before surgery, the flexible tail external to the skin was coiled under an adhesive dressing allowing the patient to return to work or home. Confirmation of target localization was imaged by ultrasound, mammography and specimen x-ray. Procedure characteristics were noted at placement and surgical removal. Results: 30 of 39 placements were performed by surgeons and 9 were placed by radiologists. All devices were placed under ultrasound guidance with an average placement time of 6 minutes. All deployments were successfully directed to the intended target without migration including those placed on a different day/time from the surgery. Localization using the Ring enabled 100% successful surgical targeting. There were no technical complications, infection or significant patient discomfort associated with placement or removal of the device. For the 36 lesions with a pre-operative cancer diagnosis, 35 (97%) had clear margins and one (3%) required re-excision for a positive DCIS margin. Conclusions: Percutaneous Ring Localization (PERL™) is a novel approach to lesion localization in the breast that solves issues associated with standard wire localization. This multi-center experience demonstrates that PERL can be utilized to guide the excision of non-palpable lesions, provides visual and tactile cues during surgery, and avoids repeated intraoperative handling of expensive scanning devices. The Ring and flexible tail allow placement at a time and location separate from the surgery with minimal discomfort and without migration. This pilot series illustrates that PERL can provide a cost-effective solution to issues with wire localization using a familiar clinical platform. Further studies are warranted based on these results. Results TableNumber of Lesions Targeted39Number of Patients Treated37Bilateral Lesions2PERL Placed by Surgeons30PERL Placed by Radiologists9Average Time to Place PERL6 minutesNumber of Cancers Localized36Final Cancer Margin Negative35Percent Re-excision (n=1)3% Citation Format: Cary S Kaufman, Michael J Cross, Kelly A Pierce, Ujwala D Rajgopal, Katherine E Rankin, Whitney A Sipe, Gail S Lebovic. A new simplified cost-effective technique for localization of non-palpable breast lesions [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-13-11.

Evaluation of the nonradioactive inducible magnetic seed system Magseed for preoperative localization of nonpalpable breast lesions - initial clinical experience.

IntroductionMany early-stage breast cancers are not palpable and thus must be localized before surgery. Detecting these lesions is crucial before they become clinically symptomatic to avoid morbidity and mortality. Nowadays, there are several new alternative techniques to traditional needle/wire localization available. These methods allow for better surgical margins, decreased costs and operating room delays, as well as improved patient satisfaction. The purpose of this study is to evaluate the nonradioactive inducible magnetic seed system Magseed (Endomagnetics Ltd, Cambridge, UK) for preoperative localization of nonpalpable breast lesions. To our knowledge, this report documents the first clinical experience with Magseed in Poland.Material and methodsA single-institution case report of 10 women with nonpalpable breast lesions localized and excised by using the Magseed surgical guidance system between November 2017 and May 2018.Results and conclusionsMagseed is an easy, sensitive and effective localization method. It is beneficial for oncoplastic outcomes and for scheduling efficiency, which overcomes many limitations of other localization methods. Surgical specimen margins were evaluated in 90% of cases as negative, with no additional re-excision. Only one patient with ductal carcinoma in situ had a positive tumor margin at the axillary side.

A German Study Comparing Standard Wire Localization With Magnetic Seed Localization of Non-palpable Breast Lesions.

Exact localization of non-palpable breast lesions is necessary to ensure that the correct lesion is removed. Conventional methods come with several disadvantages. We compared 28 patients who underwent breast-conserving surgery for a non-palpable lesion. By surgeon choice, 14 patients were assigned to undergo magnetic seed localization and 14 underwent standard wire localization. The primary outcome was the operative time, and secondary outcome was the patient pain level. The mean age was 52±10 (SD) years in the seed arm, and 55±13 years in the wire arm. The median time from skin incision to tumor extraction was not significantly different between the two groups. Patients in the wire localized group significantly more often reported pain during coughing/breathing, movement, and sleep. Using seed localization at Charité Breast Center did not lead to a significant decrease in operative time but might allow time savings once established, while increasing patient comfort and reducing organizational burden.

Results of a phase I, non-randomized study evaluating a Magnetic Occult Lesion Localization Instrument (MOLLI) for excision of non-palpable breast lesions

PurposeMagnetic Occult Lesion Localization Instrument (MOLLI) is a wireless, non-radioactive alternative for non-palpable breast lesion localization. The primary objective of this first-in-human study was to evaluate the clinical feasibility of using MOLLI for intraoperative localization of non-palpable breast lesions.MethodsTwenty women with non-palpable breast lesions at a single institution received a lumpectomy using the MOLLI guidance system. Patients were co-localized with magnetic and radioactive markers up to 7 days before excision by a dedicated breast radiologist under sonographic guidance. Both markers were localized intraoperatively using dedicated hand-held probes. The primary outcome was successful excision of the magnetic marker, confirmed radiographically and pathologically. Demographic data, margin positivity, and re-excision rates were collected. Surgical oncologists, radiologists, and pathology staff were surveyed for user satisfaction.ResultsPost-radiological analysis: Post-implant mammograms verified that 17/20 markers were placed directly in the lesion center. Radiologists reported that all marker implantations procedures were “easy” or “very easy” following a single training session. Post-surgical analysis: All MOLLI markers were successfully removed with the specimen during surgical excision. In all cases, surgeons ranked the MOLLI guidance system as “very easy” for lesion localization. Pathologic analysis: All patients had negative margins. All anatomic pathology staff ranked the MOLLI system as “very easy” to localize markers.ConclusionsThe MOLLI guidance system is a reliable and accurate method for intraoperative localization of non-palpable breast lesions. Further evaluation of the MOLLI system in studies against current standards of care is required to demonstrate system cost-effectiveness and improved patient-reported outcomes.

125I radioactive seed localization for non-palpable lesions in breast cancer

AimMarking of non-palpable breast lesions with 125I radioactive seeds is an alternative to the use of the surgical wire. The objective of this work is to present the results that we have obtained using radioactive seed localization compared to the reference technique in our center, the wire localization of non-palpable breast lesions. Material and methodLongitudinal prospective study that includes patients with histological diagnostic of breast cancer, with non-palpable lesions that are candidates to primary surgical treatment by radioactive seed localization (2016–2018) and by wire localization (2015–2016). Histological analysis of the surgical specimen was performed determining the status of surgical margins. The volume of the surgical specimen was calculated. ResultsA total of 146 patients were included, 95 who underwent surgery by radioactive seed localization and 51 by wire localization. The mean cube volume of the specimens were 135.67cm3 vs. 190.77cm3 (p=0.017), respectively. Eleven patients who underwent surgery by radioactive seed localization showed affected margins of the specimen (11.6%), versus 7 (13.2%) of wire localization group (p=0.084). Reintervention was performed in 9 of the patients marked with seeds and in 7 marked with wires (p=0.49). ConclusionThe use of 125I radioactive seeds is feasible in non-palpable breast lesions, with a low rate of reintervention and volumes of surgical specimens significantly lower than those obtained by wire localization.

Rare Complication of Stereotactic Guide-Wire Localization of Nonpalpable Breast Lesions: Breakdown of the Wire-The First Series From Turkey Involving 20 Case Analyses

Rare Complication of Stereotactic Guide-Wire Localization of Nonpalpable Breast Lesions: Breakdown of the Wire-The First Series From Turkey Involving 20 Case Analyses

Radiofrequency identification tag localization is comparable to wire localization for non-palpable breast lesions.

Radiofrequency identification (RFID) tag localization (TL) is a technique of localizing non-palpable breast lesions that can be performed prior to surgery. We sought to evaluate whether TL is comparable to wire localization (WL) in regard to specimen size, operative time, and re-excision rate. A retrospective cohort analysis was performed on TL and WL excisional biopsies and lumpectomies performed by 5 surgeons at 2 institutions. Cases were stratified by surgery type and surgical indication. Associations between localization technique and specimen volume, operative time, and re-excision rate were assessed by univariate and multivariate analyses. A total of 503 procedures were included, 147 TL (29.2%) and 356 WL (70.8%). Nineteen (12.9%) RFID tags were placed before surgery, ranging 1-22days. All intended targets were removed. TL and WL excisional biopsy and lumpectomy specimen volumes were similar (p = 0.560 and 0.494). TL and WL excisional biopsy and lumpectomy + SLNB operative times were similar (p = 0.152 and 0.158), but TL lumpectomies without SLNB took longer than WL (57min vs 49min; p = 0.027). Re-excision rates were similar by surgical procedure (p = 0.615), surgical indication (DCIS p = 0.145; invasive carcinoma p = 0.759), and confirmed by multivariable analysis (OR 0.754, 95% CI 0.392-1.450; p = 0.397). TL has similar surgical outcomes to WL with added benefit that TL can occur prior to the day of surgery. TL is an acceptable alternative to WL and should be considered for non-palpable breast lesions.

Relationship between BI-RADS and the Results of the Wire-Guided Percutaneous Localization for Non-Palpable Breast Lesions

INTRODUCTIONThe aim of this study is to evaluate the relationship between Breast Imaging Reporting and Data System and surgical biopsies that may increase effectiveness of wire-guided percutaneous localizations for non-palpable breast lesions.METHODSA retrospective review of a sample of 149 patients who underwent wire-guided localization with wide local excision for non-palpable breast lesions at the authors’ institution between January 2013 and April 2016. After IRB approval, sample patients’ records were reviewed and data were collected concerning their radiological, histological and surgical characteristics.RESULTSOne (0.67%) complication occurred related to wire migration. There were nine (6.04%) recorded cases of seroma and three (2.01%) cases of hematoma. Breast Imaging Reporting and Data System (BI-RADS) Category 4 was found to have a positive predictive value of 28.4% for breast cancer. Under Category 4 subcategorization 4A, 4B, and 4C, the number of positive lesions were two (6.89%), three (10.34%) and five (17.24%), respectively. Forty (78.43%) of the 51 patients with cancer had negative (i.e., non-cancerous) margins compared to 11 (21.57%) cases that had positive margins after the first procedure.CONCLUSIONThe BI-RADS Category 4 encompasses the majority of lesions, with approximately 70% of such biopsies lesions later found to be benign. A subcategorization of BI-RADS 4 needs further clarification in distinguishing benign vs malignant imaging characteristics. Future retrospective studies designed to identify benign vs. malignant lesions, confirmed by validating prospective studies, will better clarify a new subcategorization of BI-RADS Category 4, thus allowing surgeons and radiologists to make the best surgical recommendations for their patients.

Surgery of nonpalpable breast cancer: First step to a virtual per-operative localization? First step to virtual breast cancer localization.

Preoperative localization procedures of occult breast cancer (radioisotopic and wire localization) are invasive and uncomfortable. We have evaluated a novel technique which allows a virtual localization. Our retrospective study focused on patients treated for occult and unifocal breast cancer from September 2016 to June 2017. All patients had radioisotopic preoperative localization. We included patients who had a preoperative prone Magnetic Resonance Imaging (MRI) and an intraoperative 3D optical scan. During surgery, the surgeon localized the tumor thanks to a gamma detection probe and marked the localization on the skin with a black marker. The breast was then optically scanned. MRI was adjusted to the optical surface to match the exact breast position in the Operating Room. The virtual localization provided by the 3D breast modeling tool was retrospectively compared with the radioisotopic localization, defined as the pen mark visible in the optical scan. Nine patients were included in this feasibility study. Tumors were successfully localized in the respective breast quadrant. The mean cutaneous distance between virtual and radioisotopic localization was 1.4cm in patients with low breast volume (5/9) and 2.8cm in those with large breast volume (4/9). We developed a research prototype which enables virtual preoperative localization of nonpalpable breast lesions using MRI images and intraoperative optical scanning. Parameter optimization is required and will lead to a precise and noninvasive tool. By adding augmented reality, it will be possible to initiate a prospective study to compare this tool with the traditional localizations.

Radioactive seed vs wire localization for nonpalpable breast lesions: A single institution review

The aim of this study was to compare wire localization (WL) and radioactive seed localization (RSL) for nonpalpable breast lesions with regard to margin status, re-excision rate, procedure length, and complications related to localization. A retrospective review of the electronic health records at a single institution was performed. There was no difference in re-excision rate, margin positivity, volume of tissue removed, and complication rate for RSL vs WL (P=0.9934, P=0.9934, P=0.6645, and P=0.4716 respectively). The only difference was a longer OR time, RSL=104.408 minutes vs WL=82.386 minutes. (P=0.0163). RSL and WL are comparable techniques for localization of nonpalpable breast lesions.

Feasibility of ultrasound-guided absorbable retaining thread needle localization for nonpalpable breast lesions.

PurposeAbsorbable retaining thread (ART) needle localization utilizes a guiding needle with a thread; this technique was invented to reduce patient discomfort and wire migration. We investigated the feasibility of ultrasound (US)-guided ART needle localization for nonpalpable breast lesions.MethodsART needle localization was performed for 26 nonpalpable breast lesions in 26 patients who were scheduled to undergo surgical excision the day after localization. Seventeen breast lesions were initially diagnosed as invasive ductal carcinoma, six as ductal carcinomas in situ, and one as fibrocystic change. The other two cases without an initial pathologic diagnosis had suspicious US features, and excision was planned concomitantly with contralateral breast cancer surgery. The primary outcome was the technical success rate of ART needle localization confirmed by US immediately after the procedure, and the secondary outcomes were the percentage of clear margins on pathology and the complication rate of ART needle localization.ResultsThe technical success rate of ART needle localization was 96.2% (25 of 26 patients), and the ART was located 1 cm away from the mass in one patient (3.8%). The lesions were successfully removed with clear margins in all 26 patients. No significant complications related to ART needle localization were observed.ConclusionART needle localization can be an alternative to wire needle localization for nonpalpable breast lesions.

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.

SAVI SCOUT® localization of breast lesions as a practical alternative to wires: Outcomes and suggestions for trouble-shooting

ObjectiveThe purpose of our study was to determine the frequency of successful SAVI SCOUT® localizations, to identify the factors contributing to unsuccessful procedures, and to provide a problem-solving algorithm to address those factors. Subjects and methodsThis retrospective study was performed following IRB approval. We included all consecutive patients with SCOUT® reflector placement performed at a single tertiary-care cancer center. Each case was reviewed and the following data were recorded: patient age, breast density, localization target, imaging modality used for guidance, post procedure mammogram reflector to skin and reflector to target distances, presence of the reflector in the specimen radiograph, excisional biopsy pathology and any procedure complications. ResultsIn 129 women, 152 SAVI SCOUT® reflectors were placed. Most patients had only 1 reflector placed, but 19 (15%) women had multiple reflectors placed for the purposes of bracketing, multiple excisions in 1 breast, bilateral excisions, or any combination thereof. The most common target was a mass (65%) and the most common modality for guidance was ultrasound (73%). SAVI SCOUT® localization was successful in 97%of reflectors, including 89% of reflectors targeting axillary lymph nodes. The most common failure encountered was the inability to obtain a signal in the radiology suite, due to (1) excessive target depth for the radiology suite handpiece and console, (2) obscuration by a hematoma, or (3) faulty reflector. No post-operative complications occurred. ConclusionThe SAVI SCOUT® surgical guidance system is an accurate and reliable method for localization of non-palpable breast lesions, bracketing, and axillary lymph nodes.

Wire versus radioactive seed in the localisation of non-palpable breast lesions: A systematic review

Wire versus radioactive seed in the localisation of non-palpable breast lesions: A systematic review

Radar-guided vs. wire localization for non-palpable breast lesions.

e18525Background: Wire localization (WL) has been the standard for intraoperative localization for non-palpable breast lesions for many years. Wires must be placed on the same day as surgery, which...

270 (PB-065) - Magnetic Seed Localization for Nonpalpable Breast Lesions: First experiences

270 (PB-065) - Magnetic Seed Localization for Nonpalpable Breast Lesions: First experiences

Initial Clinical Experience With an Inducible Magnetic Seed System for Preoperative Breast Lesion Localization

The purpose of this study is to evaluate a nonradioactive inducible magnetic seed system (Magseed, Endomag) for preoperative localization of nonpalpable breast lesions. All of the 73 seeds placed in the first 4 months of clinical use were successfully placed and all were successfully retrieved intraoperatively. The mean time from seed placement to surgery was 3 days. Early clinical experience suggests that Magseed is an effective and accurate means of preoperative breast lesion localization.

Multimodality Imaging of Charcoal Granuloma Mimicking Breast Cancer Recurrence

: Charcoal is a biologically inert material used for the preoperative localization of nonpalpable breast lesions; its foreign body reactions have occasionally been reported. Although a few case reports on the formation of charcoal granulomas in the breast because of such reactions exist, to the best of our knowledge, no report includes breast-imaging findings obtained using multiple modalities. Here we report a case of two charcoal granulomas that mimicked breast cancer recurrence and provide breast-imaging findings obtained using mammography, ultrasonography, magnetic resonance imaging, and positron emission tomography/computed tomography. We also discuss the radiological and pathological features of charcoal granulomas. Awareness of breast imaging findings using multiple modalities along with the clinical and pathological features of charcoal granulomas helps in the differential diagnoses of newly detected lesions on postoperative follow-ups and reduces the need of unnecessary invasive procedures.

Assessment of Ultrasound / Radio-guided Occult Lesion Localization in Non-palpable Breast Lesions.

Objective(s):Controversy exists about the localization of non-palpable breast lesions. In many countries, the gold standard for the diagnosis of these lesions is needle localization due to its accuracy. This study sought to compare the ultrasound- and radio-guided occult lesion localization (ROLL) as a simple method with the conventional procedures in terms of their diagnostic power.Methods:This study was conducted on 94 patients with non-palpable breast lesions detected by ultrasonography and localized by the combination of ultrasonography and using radiopharmaceuticals. One to ten hours prior to surgery, 0.1-0.2 ml (equivalent to 0.5-1 mCi) of Tc-99m-phytate was injected to the lesion under the guidance of ultrasonography. Then, the lesion was localized using a hand-held gamma probe, and excision of the lesion was performed according to its radioactivity signal. Data analysis was performed using SPSS, version 16.Results:Benign and malignant pathologic results were observed in 77 (81.9%) and 17(18.1%) of the patients, respectively, and the mean volume of the excised tissue was 26.29±27 mm³. 79 patients had a solitary lesion (84%), 55 in the left breast (58.5%) and 39 in superolateral quadrant (41.5%). The mean size of the lesions was 15.7 mm in diameter (ranging from 4 to 34 mm). Additionally, there was a need to secondary surgery in 3 (3.2%) patients and inappropriate localization in 6 (6.4%) patients (subcutaneous or intra-ductal spread of radiodrug).Conclusion:Combination of ultrasound- and radio-guided localization methods for localizing non-palpable breast lesions is a simple and acceptable method for localization with no significant complications. For radio-drug spread and subsequent excessive excised tissue volume, subcutaneous and intra-ductal lesions are not suitable indication for ROLL.

Radio-localization of Non-Palpable Breast Lesions Under Ultrasonographic Guidance: Current Status and Future Perspectives.

Due to the spread of mammographic screening programs, a constant increase of clinically-occult breast cancer diagnosis has been registered. A correct approach to nonpalpable breast lesions requires an accurate intra-operative localization in order to achieve a complete surgical resection. The aim of this paper is to describe the state of the art of the US-guided procedures such as Radio-guided Occult Lesion Localization (ROLL) and Radio-guided Seed Localization (RSL) in comparison to the most widely adopted Wire-Guided Localization (WGL). Links to full text papers and abstracts published in the last 25 years regarding localization of non-palpable breast lesions were researched using PubMed service of US National Library of Medicine. Using the term "non-palpable breast lesions localization", different localization techniques were considered and analyzed. Human studies, published in English, French, German, Italian, and Spanish in journals with an impact factor index, were taken into account, independently of the type of article (clinical trial, review, editorial, etc.) or radiopharmaceutical used. Since the aim was to assess the clinical value of the procedures, a higher relevance was assigned to studies with significantly high number of patients and to those comparing at least two localization techniques. The reliability of each technique was evaluated taking into account several parameters such as correlation index between two localization procedures, risk of complications, lesion margin involvement and rate re-operation. Since their introduction in clinical practice, several randomized clinical trials and meta-analyses showed the accuracy and reliability of radio-guided procedures performed under ultrasonographic guidance. ROLL and RSL offer a practical approach to the management of clinically-occult breast lesions.