Original Research
Women's Imaging
August 7, 2018

Evaluation of a Nonradioactive Magnetic Marker Wireless Localization Program

Abstract

OBJECTIVE. The purpose of this study is to evaluate the feasibility and effectiveness of a nonradioactive magnetic marker wireless localization technique.
MATERIALS AND METHODS. A retrospective review was performed of consecutive patients who underwent image-guided needle localization with nonradioactive magnetic markers and subsequent surgical excision from March to August 2017. Indications for marker placement, lesion type, imaging guidance used for marker placement, postprocedure mammographic imaging and reports, surgical reports, and surgical margin status were reviewed.
RESULTS. A total of 188 patients (mean age, 59 years; range, 22–89 years) underwent image-guided localization with 213 magnetic markers and subsequent surgical excision. The indications for marker placement included invasive carcinoma (96 markers [45.1%]), ductal carcinoma in situ (41 markers [19.2%]), and high-risk lesions (71 markers [33.3%]). Localization markers were most commonly placed for masses (96 markers [45.1%]) and were deployed under mammographic guidance (160 markers [75.1%]) or sonographic guidance (53 markers [24.9%]). Technical success, which was defined as placement of the magnetic marker within 1 cm of the target, was achieved for 206 of 213 markers (96.7%). All 213 markers were successfully retrieved at surgery. Of 137 cases of in situ or invasive carcinoma, 30 (21.9%) had tumor-positive or close surgical margins that required reexcision. No major or minor complications were observed during marker placement, intraoperatively, or postoperatively.
CONCLUSION. Image-guided needle localization with magnetic markers is a safe, feasible, and effective method for localizing breast lesions. Magnetic marker localization has the potential to replace conventional wire needle localization and radioactive seed needle localization for lesions that require surgical excision.
The conventional technique for pre-operative localization of nonpalpable and percutaneously biopsied breast lesions involves the use of needle-wire assemblies, which are placed on the day of surgery. Radioactive seeds, which can be placed before the day of surgery, have emerged as a safe and effective alternative to wire localizations [13]. More recently, marker localization systems that do not use radioactive material have been introduced as a technique that is a potential alternative to radioactive seed and wire localizations [48]. A new localization technique that uses nonradioactive magnetic markers (Magseed, Endomagnetics) has recently been introduced.
Several studies have reported the advantages associated with radioactive seeds, which have become increasingly accepted and used [13]. Compared with wire localizations, radioactive seeds are associated with similar, if not slightly improved, tumor-negative surgical margin rates and reexcision rates [13]. The advantages of wireless localizations include improved scheduling times (with seeds placed before the day of surgery), shorter localization procedure times, improved patient tolerance, and reduced costs along with improved resource and scheduling efficiencies [13, 913]. The disadvantages of wire localizations include the potential for wire breakage and displacement [1417].
Nonradioactive markers offer several potential advantages over radioactive seeds [48]. Unlike the extensive regulatory requirements for the use of radioactive seeds that are associated with increased costs and greater staffing needs, nonradioactive markers do not have the need for such regulatory approval [7, 18]. Certain nonradioactive markers may be placed weeks or even months before surgery, whereas most radioactive seeds typically are removed within 5 days after placement [17, 19]. The feasibility of nonradioactive reflector-guided breast lesion localization (SAVI SCOUT, Cianna Medical) has been studied; however, to our knowledge, at the time of the writing of this article, there were no published studies on nonradioactive magnetic markers (Magseed, Endomagnetics) [48]. The purpose of the present study was to evaluate the feasibility and effectiveness of a nonradioactive magnetic marker localization program.

Materials and Methods

Study Subjects

This retrospective study, which was performed at Massachusetts General Hospital, a large academic medical center, was approved by the hospital's institutional review board. The study was HIPAA compliant, and the need to obtain informed consent was waived. The Standards for the Reporting of Diagnostic Accuracy checklist was used [20].
The study cohort comprised consecutive patients who underwent image-guided wireless needle localization with magnetic markers from March 1, 2017, to August 31, 2017. All patients underwent imaging both preoperatively and at the time of localization, and all had specimen radio-graphs available for review.

Localization Technique

Localization procedures were performed under mammographic guidance (with full-field 2D digital mammography or digital breast tomosynthesis) or sonographic guidance with use of a 12-5–MHz transducer. Localization procedures were performed by one of nine fellowship-trained dedicated breast imaging radiologists or a radiology trainee (a breast imaging fellow or senior radiology resident) directly supervised by the attending radiologist for the duration of the procedure. Surgeries were performed by one of five dedicated breast surgeons.
The magnetic markers used were metallic (made of medical-grade low-nickel stainless steel), nonradioactive, magnetic devices that are 5 mm in length and 1 mm in diameter (Magseed, Endomagnetics) [21] (Fig. 1). The magnetic markers were deployed using an 18-gauge needle.
Fig. 1A —Components used in nonradioactive magnetic marker wireless localization program. (Reprinted with permission from Endomagnetics)
A, Schematics show metallic marker (Magseed, Endomagnetics) (A; inset, B) and probe (Sentimag, Endomagnetics) (B) used in nonradioactive magnetic marker wireless localization program.
Fig. 1B —Components used in nonradioactive magnetic marker wireless localization program. (Reprinted with permission from Endomagnetics)
B, Schematics show metallic marker (Magseed, Endomagnetics) (A; inset, B) and probe (Sentimag, Endomagnetics) (B) used in nonradioactive magnetic marker wireless localization program.
At the time this article was written, the U.S. Food and Drug Administration had provided approval for the markers to be placed in the breast up to 30 days before the surgical procedure was performed, with no decay in signal occurring during that time. During the study, all but two markers were placed on the day of surgery. Although an advantage of this technique is that the localization procedure did not need to occur on the day of surgery, we thought that it was necessary to determine the feasibility of this technique before changing the workflow in our practice.
Once in the operating room, the surgeon localized the marker with use of the manufacturer's probe (Sentimag, Endomagnetics), which temporarily magnetized the markers (Fig. 1). As the surgeon scanned the breast with the probe, the Sentimag instrument displayed numeric feedback and also produced an audio tone, which was related to the distance of the magnetic marker from the probe. Once the surgeon made an incision, the numeric feedback was used to guide the surgeon to the magnetic marker. The use of specialized, nonferromagnetic surgical instruments was required because the surgical instruments that are typically used interfere with the magnetic signal. Radiographs were obtained after excision to document successful marker retrieval.

Data Collection and Statistical Analysis

Medical record review was performed in accordance with the ethics guidelines of the institutional review board. Medical records were reviewed to determine patient age, the number of localization markers placed, indications for marker placement, lesion type (asymmetry, architectural distortion, calcifications, or mass), the imaging guidance used for marker placement, postprocedure mammographic imaging and reports, surgical reports, and surgical margin status. Final surgical specimen radiographs were reviewed for all patients. Descriptive statistics were calculated using spreadsheet software (Excel 2013, Microsoft).

Results

During the study, 188 women (mean age, 59 years; range, 22–89 years) underwent image-guided localization with nonradioactive magnetic markers and subsequent surgical excision. A total of 164 patients had a single localization marker placed, and 24 patients underwent bracketing or had more than one lesion localized, for a total of 213 magnetic markers placed.
Indications for placement of the 213 markers included invasive carcinoma for 96 markers (45.1%), ductal carcinoma in situ for 41 markers (19.2%), high-risk lesions for 71 markers (33.3%), and lesions that were benign but discordant on core needle biopsy for five markers (2.3%). Localization markers were most commonly placed for masses (96 markers; 45.1%) or calcifications (68 markers; 31.9%) and were deployed under either mammographic guidance (160 markers; 75.1%) or sonographic guidance (53 markers; 24.9%). Of the 160 markers deployed under mammographic guidance, 42 markers (26.3%) were placed under 2D digital mammography guidance, and 118 (73.8%) were placed under tomosynthesis guidance.
Technical success, which was defined as placement of the magnetic marker within 1 cm of the target on the postprocedural mammogram, was achieved for 206 of 213 markers (96.7%) (Fig. 2). Seven markers (3.3%) were displaced more than 1 cm from the target, and all of these markers were deployed using an upright digital breast tomosynthesis system during our institution's initial experience with tomosynthesis-guided needle localization procedures (Fig. 3). For patients who required placement of more than one marker in the ipsilateral breast (for bracketing or for more than one lesion), the mean distance between markers was 29 mm (range, 3–68 mm).
Fig. 2A —50-year-old woman who presented with mass at 11-o'clock position in left breast that was detected on screening examination. Mass was biopsied under ultrasound guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. In first magnetic marker localization performed at our institution, mass was localized under ultrasound guidance with use of single magnetic marker, and marker was successfully retrieved at surgery.
A, Craniocaudal (A) and mediolateral oblique (B) mammographic images show mass (arrow) in left breast.
Fig. 2B —50-year-old woman who presented with mass at 11-o'clock position in left breast that was detected on screening examination. Mass was biopsied under ultrasound guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. In first magnetic marker localization performed at our institution, mass was localized under ultrasound guidance with use of single magnetic marker, and marker was successfully retrieved at surgery.
B, Craniocaudal (A) and mediolateral oblique (B) mammographic images show mass (arrow) in left breast.
Fig. 2C —50-year-old woman who presented with mass at 11-o'clock position in left breast that was detected on screening examination. Mass was biopsied under ultrasound guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. In first magnetic marker localization performed at our institution, mass was localized under ultrasound guidance with use of single magnetic marker, and marker was successfully retrieved at surgery.
C, Transverse ultrasound image (C) shows magnetic marker (arrow) within mass.
Fig. 2D —50-year-old woman who presented with mass at 11-o'clock position in left breast that was detected on screening examination. Mass was biopsied under ultrasound guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. In first magnetic marker localization performed at our institution, mass was localized under ultrasound guidance with use of single magnetic marker, and marker was successfully retrieved at surgery.
D, Postlocalization craniocaudal (D) and mediolateral oblique (E) mammographic images show successful magnetic marker placement (arrow) adjacent to biopsy clip placed at time of biopsy.
Fig. 2E —50-year-old woman who presented with mass at 11-o'clock position in left breast that was detected on screening examination. Mass was biopsied under ultrasound guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. In first magnetic marker localization performed at our institution, mass was localized under ultrasound guidance with use of single magnetic marker, and marker was successfully retrieved at surgery.
E, Postlocalization craniocaudal (D) and mediolateral oblique (E) mammographic images show successful magnetic marker placement (arrow) adjacent to biopsy clip placed at time of biopsy.
Fig. 2F —50-year-old woman who presented with mass at 11-o'clock position in left breast that was detected on screening examination. Mass was biopsied under ultrasound guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. In first magnetic marker localization performed at our institution, mass was localized under ultrasound guidance with use of single magnetic marker, and marker was successfully retrieved at surgery.
F, Specimen radiograph shows successful retrieval of mass, biopsy clip (circle), and magnetic marker (rectangle).
Fig. 3A —87-year-old woman who presented with mass at 4-o'clock position in left breast that was detected on screening examination. Mass was biopsied under tomosynthesis guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. Biopsy clip was displaced laterally by 1 cm at time of biopsy. Mass was localized under tomosynthesis guidance with magnetic marker.
A, Craniocaudal (A) and mediolateral (B) mammographic images show mass (arrow) in left breast with lateral displacement of biopsy clip.
Fig. 3B —87-year-old woman who presented with mass at 4-o'clock position in left breast that was detected on screening examination. Mass was biopsied under tomosynthesis guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. Biopsy clip was displaced laterally by 1 cm at time of biopsy. Mass was localized under tomosynthesis guidance with magnetic marker.
B, Craniocaudal (A) and mediolateral (B) mammographic images show mass (arrow) in left breast with lateral displacement of biopsy clip.
Fig. 3C —87-year-old woman who presented with mass at 4-o'clock position in left breast that was detected on screening examination. Mass was biopsied under tomosynthesis guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. Biopsy clip was displaced laterally by 1 cm at time of biopsy. Mass was localized under tomosynthesis guidance with magnetic marker.
C, Mammographic image shows mediolateral approach used for localization of mass (arrow) under tomosynthesis guidance.
Fig. 3D —87-year-old woman who presented with mass at 4-o'clock position in left breast that was detected on screening examination. Mass was biopsied under tomosynthesis guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. Biopsy clip was displaced laterally by 1 cm at time of biopsy. Mass was localized under tomosynthesis guidance with magnetic marker.
D, Craniocaudal (D) and mediolateral (E) mammographic images show that magnetic marker (arrow) was displaced laterally by 3 cm when breast was released from compression.
Fig. 3E —87-year-old woman who presented with mass at 4-o'clock position in left breast that was detected on screening examination. Mass was biopsied under tomosynthesis guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. Biopsy clip was displaced laterally by 1 cm at time of biopsy. Mass was localized under tomosynthesis guidance with magnetic marker.
E, Craniocaudal (D) and mediolateral (E) mammographic images show that magnetic marker (arrow) was displaced laterally by 3 cm when breast was released from compression.
Fig. 3F —87-year-old woman who presented with mass at 4-o'clock position in left breast that was detected on screening examination. Mass was biopsied under tomosynthesis guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. Biopsy clip was displaced laterally by 1 cm at time of biopsy. Mass was localized under tomosynthesis guidance with magnetic marker.
F, Ultrasound image shows magnetic marker (arrow) after patient subsequently underwent successful repeat placement of marker.
Fig. 3G —87-year-old woman who presented with mass at 4-o'clock position in left breast that was detected on screening examination. Mass was biopsied under tomosynthesis guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. Biopsy clip was displaced laterally by 1 cm at time of biopsy. Mass was localized under tomosynthesis guidance with magnetic marker.
G, Final craniocaudal (G) and mediolateral (H) mammographic images show final position of markers (arrows).
Fig. 3H —87-year-old woman who presented with mass at 4-o'clock position in left breast that was detected on screening examination. Mass was biopsied under tomosynthesis guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. Biopsy clip was displaced laterally by 1 cm at time of biopsy. Mass was localized under tomosynthesis guidance with magnetic marker.
H, Final craniocaudal (G) and mediolateral (H) mammographic images show final position of markers (arrows).
Fig. 3I —87-year-old woman who presented with mass at 4-o'clock position in left breast that was detected on screening examination. Mass was biopsied under tomosynthesis guidance, with pathologic analysis indicating grade 2 invasive ductal carcinoma. Biopsy clip was displaced laterally by 1 cm at time of biopsy. Mass was localized under tomosynthesis guidance with magnetic marker.
I, Specimen radiograph shows successful retrieval of mass, biopsy clip (small rectangle), and two magnetic markers (large rectangles).
All 213 markers were successfully retrieved at surgery. Of 137 cases of ductal carcinoma in situ or invasive carcinoma, 30 (21.9%) had tumor-positive or close surgical margins requiring reexcision. No major or minor complications were observed during marker placement, intraoperatively, or postoperatively.

Discussion

Multiple previously published studies have examined wire, radioactive seed, and reflector-guided (SAVI SCOUT, Cianna Medical) localization systems, but, to our knowledge, there are no published studies on nonradioactive magnetic marker localization systems [113]. Our study of 213 magnetic markers in 188 patients, which is also, to our knowledge, the largest study of any nonradioactive localization system, shows that image-guided needle localization with magnetic markers is safe, feasible, and effective.
In our study cohort, 100% of 213 magnetic markers were successfully retrieved at surgical excision, and 96.7% (206 markers) were placed within 1 cm of the target. Seven markers (3.3%), all of which were deployed using an upright digital breast tomosynthesis system during our institution's initial experience with tomosynthesis-guided needle localization procedures, were displaced more than 1 cm from the target. We suspect that the accordion effect occurred on release of the patient's breast from compression, which caused migration of the marker. In mammography-guided biopsy, the accordion effect is a well-established phenomenon in which postbiopsy clips can be displaced along the direction of the needle track on release of the breast from compression [2227]. Since our initial experience with tomosynthesis-guided needle localization procedures, we have attempted to lessen the accordion effect by using less compression during the procedure and by holding and slowly releasing the breast from compression after marker placement. During the study, 94.1% (111/118) of the markers were successfully placed (without displacement) under tomosynthesis guidance.
In the present study, 21.9% (30/137) of cases of malignancy (ductal carcinoma in situ or invasive carcinoma) had positive or close surgical margins that required reexcision. This result is similar to the results of a recent study of the SAVI SCOUT localization system in which 25.9% (14/54) of malignancies had positive or close surgical margins [8]. In a larger study of the SAVI SCOUT system, 29.7% (30/101) of patients with malignancy had positive or close surgical margins, although only 16.8% (17/101) underwent reexcision [5]. Our results with magnetic markers and the previously mentioned results of reflector-guided localization in this article are comparable to reports of margin status with radioactive seeds and are equal to or better than the results associated with wire localization systems. One study of radioactive seeds versus wire localizations found significantly lower positive margin rates with the use of seeds (27% vs 46%, p < 0.001), whereas another showed no significant difference (21.1% [41/194] vs 23.5% [36/153], p = 0.61) [13, 28].
Although magnetic markers can be placed before the day of surgery, are not radioactive, and can overcome some of the drawbacks of wire localizations, they have several limitations. Magnetic markers cost more than wires and radioactive seeds, and there are also costs associated with initial purchase of the probes; however, reducing operating room–related delays associated with wire localizations may result in financial savings, as would eliminating costs associated with nuclear medicine support of radioactive seed programs [13]. In addition, nonmagnetic retractors are required to eliminate interference with the detection probe. Similar to radioactive seeds, magnetic markers cannot be repositioned once deployed [29]. As such, careful attention of marker placement in subtle findings is necessary.
Our study has several limitations. First, it was conducted by dedicated breast imaging radiologists, breast surgeons, and pathologists at an academic institution, and thus the results may not be generalizable to all institutions. Second, this study reflects our initial experiences with a new technology, and both the radiologists and the surgeons involved were learning how to use the magnetic markers. Third, patients were chosen to have magnetic markers placed on the basis of surgeon preference and availability of the required probe in the operating room, which potentially introduced a selection bias.
The present study shows that needle localization with nonradioactive magnetic markers is a safe, feasible, and effective method for image-guided surgical excision of breast lesions. Future work will focus on a multi-factorial economic analysis, in addition to an assessment of patient satisfaction. Magnetic marker localization has the potential to replace conventional wire needle localization and radioactive seed needle localization for lesions that require surgical excision.

Footnote

C. D. Lehman received a research grant from and serves on an advisory board for GE Healthcare.

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Information & Authors

Information

Published In

American Journal of Roentgenology
Pages: 940 - 945
PubMed: 30085842

History

Submitted: January 28, 2018
Accepted: March 27, 2018
Version of record online: August 7, 2018

Keywords

  1. breast cancer
  2. image-guided intervention
  3. nonradioactive
  4. wireless localization

Authors

Affiliations

Leslie R. Lamb
Department of Radiology, Massachusetts General Hospital, 55 Fruit St, WAC 240, Boston, MA 02114.
Manisha Bahl
Department of Radiology, Massachusetts General Hospital, 55 Fruit St, WAC 240, Boston, MA 02114.
Michelle C. Specht
Department of Surgery, Massachusetts General Hospital, Boston, MA.
Helen Anne D'Alessandro
Department of Radiology, Massachusetts General Hospital, 55 Fruit St, WAC 240, Boston, MA 02114.
Constance D. Lehman
Department of Radiology, Massachusetts General Hospital, 55 Fruit St, WAC 240, Boston, MA 02114.

Notes

Address correspondence to M. Bahl ([email protected]).

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