Utilization of multiple SAVI SCOUT surgical guidance system reflectors in the same breast: A single-institution feasibility study.

SAVI SCOUT Surgical Guidance System has been shown to be a reliable and safe alternative to wire localization in breast surgery. This study evaluated the feasibility of using multiple reflectors in the same breast. We performed an IRB-approved, HIPAA-compliant, single-institution retrospective review of 183 patients who underwent breast lesion localization and excision using SAVI SCOUT Surgical Guidance System (Cianna Medical) between June 2015 and January 2017. We performed a subset analysis in 42 patients in whom more than one reflector was placed. Specimen radiography, pathology, distance between reflectors, target removal, margin positivity, and complications were evaluated. Among 183 patients, 42 patients had more than one reflector placed in the same breast to localize 68 lesions. Benign (n = 6, 8.8%), high-risk (n = 23, 33.8%), and malignant (n = 39, 57.4%) lesions were included. Thirty-six patients (85.7%) had a total of 2 reflectors placed and 6 patients had a total of 3 reflectors placed (14.3%). The indications for multiple reflector placement in the same breast included multiple separate lesions (n = 23) and bracketing of large lesions (n = 19). The mean distance between the reflectors was 42 mm (22-93 mm). All lesions were successfully targeted and retrieved. Of 39 malignant lesions, 10.3% (n = 4) had positive margins and 10.3% (n = 4) had close (<1 mm) margins at surgery. All patients with positive margins underwent re-excision. No complications occurred preoperatively, intra-operatively, or postoperatively. The use of multiple SAVI SCOUT reflectors for localizing multiple lesions in the same breast or bracketing large lesions is feasible and safe.

Beyond Wires and Seeds: Reflector-guided Breast Lesion Localization and Excision.

Purpose To evaluate outcomes of Savi Scout (Cianna Medical, Aliso Viejo, Calif) reflector-guided localization and excision of breast lesions by analyzing reflector placement, localization, and removal, along with target excision and rates of repeat excision (referred to as re-excision). Materials and Methods A single-institution retrospective review of 100 women who underwent breast lesion localization and excision by using the Savi Scout surgical guidance system from June 2015 to May 2016 was performed. By using image guidance 0-8 days before surgery, 123 nonradioactive, infrared-activated, electromagnetic wave reflectors were percutaneously inserted adjacent to or within 111 breast targets. Twenty patients had two or three reflectors placed for bracketing or for localizing multiple lesions, and when ipsilateral, they were placed as close as 2.6 cm apart. Target and reflector were localized intraoperatively by one of two breast surgeons who used a handpiece that emitted infrared light and electromagnetic waves. Radiographs of the specimen and pathologic analysis helped verify target and reflector removal. Target to reflector distance was measured on the mammogram and radiograph of the specimen, and reflector depth was measured on the mammogram. Pathologic analysis was reviewed. Re-excision rates and complications were recorded. By using statistics software, descriptive statistics were generated with 95% confidence intervals (CIs) calculated. Results By using sonographic (40 of 123; 32.5%; 95% CI: 24.9%, 41.2%) or mammographic (83 of 123; 67.5%; 95% CI: 58.8% 75.1%) guidance, 123 (100%; 95% CI: 96.4%, 100%) reflectors were placed. Mean mammographic target to reflector distance was 0.3 cm. All 123 (100%; 95% CI: 96.4%, 100%) targets and reflectors were excised. Pathologic analysis yielded 54 of 110 malignancies (49.1%; 95% CI: 39.9%, 58.3%; average, 1.0 cm; range, 0.1-5 cm), 32 high-risk lesions (29.1%; 95% CI: 21.4%, 38.2%), and 24 benign lesions (21.8%; 95% CI: 115.1%, 30.4%). Four of 54 malignant cases (7.4%; 95% CI: 2.4%, 18.1%) demonstrated margins positive for cancer that required re-excision. Five of 110 radiographs of the specimen (4.5%; 95% CI: 1.7%, 10.4%) demonstrated increased distance between the target and reflector distance of greater than 1.0 cm (range, 1.1-2.6 cm) compared with postprocedure mammogram the day of placement, three of five were associated with hematomas, two of five migrated without identifiable cause. No related postoperative complications were identified. Conclusion Savi Scout is an accurate, reliable method to localize and excise breast lesions with acceptable margin positivity and re-excision rates. Bracketing is possible with reflectors as close as 2.6 cm. Savi Scout overcomes many limitations of other localization methods, which warrants further study. © RSNA, 2017.

Breast cancer molecular subtype as a predictor of the utility of preoperative MRI.

OBJECTIVE: The purpose of this study was to discern whether breast cancer molecular subtype, a known prognostic indicator, can be used to select patients with the highest likelihood of having clinically significant additional findings on breast MRI. MATERIALS AND METHODS: A database review from January 2010 through December 2013 identified 299 patients who underwent preoperative breast MRI with tumors classifiable into molecular subtypes. Subtypes were classified on the basis of immunohistochemical staining surrogates as luminal A (hormone receptor [ER or PR] positive, ERBB2 [formerly HER2 or HER2/neu] negative, luminal B (hormone receptor positive, ERBB2 positive), ERBB2 (hormone receptor negative, ERBB2 positive), or basal (hormone receptor and ERBB2 negative). Univariate and multivariate logistic regression analyses were used to determine the association between subtype and additional breast MRI findings, including multicentric or multifocal disease, contralateral disease, chest wall involvement, skin and nipple involvement, and internal mammary and axillary lymphadenopathy. RESULTS: The subtype distribution was luminal A, 70.6% (211/299); luminal B, 14.1% (42/299); ERBB2, 5.4% (16/299); and basal, 10.0% (30/299). ERBB2 and luminal B sub-types were more often associated with multicentric disease (25.0% and 26.2%), multifocal disease (37.5% and 35.7%), and axillary disease (50.0% and 45.2%) than were luminal A cancers (multicentric disease, 10.9%; multifocal disease 20.4%; axillary disease, 22.7%) (p < 0.001). In multivariate analysis, after control for patient age, tumor size, and nuclear grade, patients with ERBB2-overexpressing tumors were 2.4 times as likely as patients with luminal A tumors to have multicentric disease (p = 0.016), 2.0 times as likely to have multifocal disease (p = 0.024), 1.7 times as likely to have skin and nipple involvement (p = 0.013), and 1.9 times as likely to have axillary disease (p = 0.011). CONCLUSION: Preoperative MRI may most benefit patients with tumors with ERBB2 overexpression because of the increased likelihood of the presence of additional disease.

Management of Radiographic Lesions of the Breast.

Breast imaging plays an essential role in the diagnosis and management of breast disease. From screening asymptomatic patients to evaluating clinical abnormalities on diagnostic studies, breast imaging provides critical information to the breast surgeon. Available imaging studies include those that have been proved over many years, like mammography, and those that take advantage of increasingly sophisticated technology, like breast MRI. Image-guided biopsy provides a safe means of evaluating indeterminate findings on imaging. Understanding how these tools are best used can help breast surgeons provide the best care for their patients.

Results of MR imaging screening for breast cancer in high-risk patients with lobular carcinoma in situ.

PURPOSE: To determine the outcome of screening breast magnetic resonance (MR) imaging examinations performed in patients with lobular carcinoma in situ (LCIS) at the authors' institution. MATERIALS AND METHODS: This study was approved by the institutional review board and was compliant with HIPAA. Retrospective review of screening breast MR imaging examinations at the institution from 1996 through September 2009 was performed in patients with prior biopsies demonstrating LCIS. Patients with prior breast cancer diagnosis were excluded. American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) recommendations were recorded. Pathologic results of all consequent biopsies were obtained from the electronic medical records. RESULTS: A total of 445 breast MR examinations in 198 patients with LCIS were identified. Of these, 308 were screening examinations in 134 patients. One patient was a BRCA mutation carrier and was excluded. Of the remaining 307 screening examinations, 254 (82.7%) had BI-RADS category 1 or 2 findings; 27 (8.8%) had BI-RADS category 3 findings; and 27 (8.8%) had B-IRADS category 4 or 5 findings. Of the 27 studies that led to a biopsy recommendation, 10 (37%) yielded benign pathologic findings, five (18.5%) yielded malignant pathologic findings, and seven (25.9%) yielded high-risk lesions. Of the 27 studies with BI-RADS 3 findings, two (7.4%) resulted in biopsy, findings of both were benign. Overall, malignancy was detected in five of 307 screening studies (1.6%) and in five of 133 screened patients (3.8%). The positive predictive value (PPV) of these screening studies for which biopsy was recommended was 18.5%. The PPV 3 (studies for which biopsy was recommended and actually performed, as described in the BI-RADS guidelines) was 23.8%. CONCLUSION: Screening breast MR imaging helped identify breast cancer in LCIS patients at a rate similar to that shown in high-risk populations for whom screening breast MR imaging is currently consistently recommended.

Are Mammographically Occult Additional Tumors Identified More Than 2 Cm Away From the Primary Breast Cancer on MRI Clinically Significant?

RATIONALE AND OBJECTIVES: To evaluate the clinical significance of mammographically occult additional tumors identified more than 2cm away from the primary breast cancer on preoperative magnetic resonance imaging (MRI). MATERIALS AND METHODS: An Institutional Review Board approved review of consecutive preoperative breast MRIs performed from 1/1/08 to 12/31/14, yielded 667 patients with breast cancer. These patients underwent further assessment to identify biopsy proven mammographically occult breast tumors located more than 2cm away from the edge of the primary tumor. Additional MRI characteristics of the primary and secondary tumors and pathology were reviewed. Statistical analysis was performed using SPSS (v. 24). RESULTS: Of 667 patients with breast cancer, 129 patients had 150 additional ipsilateral mammographically occult tumors that were more than 2cm away from the edge of the primary tumor. One hundred twelve of 129 (86.8%) patients had one additional tumor and 17/129 (13.2%) had two or more additional tumors. In 71/129 (55.0%), additional tumors were located in a different quadrant and in 58/129 (45.0%) additional tumors were in the same quadrant but ≥2cm away. Overall, primary tumor size was significantly larger (mean 1.87± 1.25 cm) than the additional tumors (mean 0.79 ± 0.61cm, p < 0.001). However, in 20/129 (15.5%) the additional tumor was larger and in 26/129 (20.2%) the additional tumor was ≥1cm. The primary tumor was significantly more likely to be invasive (81.4%, 105/129) compared to additional tumors (70%, 105/150, p = 0.03). In 9/129 (7.0%) patients, additional tumors yielded unsuspected invasive cancer orhigher tumor grade. The additional tumor was more likely to be nonmass lesion type (37.3% vs 24% p = 0.02) and focus lesion type (10% vs 0.08%, p < 0.001) compared to primary tumor. CONCLUSION: Mammographically occult additional tumors identified more than 2cm away from the primary breast tumor on MRI are unlikely to be surgically treated if undiagnosed and may be clinically significant.

Reflector-guided breast tumor localization versus wire localization for lumpectomies: A comparison of surgical outcomes.

PURPOSE: To compare surgical outcomes of SAVI SCOUT reflector localization (SSL) versus wire localization (WL) for breast tumors. METHODS: Retrospective review of 42 SSL cases and 42 WL cases. WL patients were consecutively matched for clinical-pathologic features. Final surgical outcome measures were tumor specimen volume, margin status, and re-excision rates. RESULTS: No significant differences were present in median specimen volumes (SSL-15.2cm3 vs. WL-16.3cm3), positive margin rate (SSL-9.5% vs. WL-7.1%), close margin rate (SSL-7.1% vs. WL-11.9%) or re-excision rate (SSL-7.1% vs. WL-9.5%). CONCLUSION: SSL is an acceptable alternative to WL with no significant differences in surgical outcomes.

Evaluation of association between degree of background parenchymal enhancement on MRI and breast cancer subtype.

PURPOSE: Evaluate possible association between BPE and breast cancer tumor type/prognostic markers. METHODS: IRB approved retrospective study from 1/2010-1/2014 identified 328 patients who had breast MRI and available clinical/pathology data. BPE was categorized according to BI-RADS. The association between BPE and breast cancer molecular subtype/prognostic factors was evaluated. RESULTS: No significant association was present between high BPE and the following: HER2+ tumors, basal tumors, tumors with axillary nodal disease, high nuclear grade tumors, high Ki-67 index tumors or larger tumors. CONCLUSION: Patients with high BPE may be at increased risk for breast cancer but not necessarily for those cancer subtypes with a poor prognosis.

The unusual suspects: A review of unusual benign and malignant male breast imaging cases.

Male breast disease is uncommon. Men presenting with breast symptoms may represent unique diagnostic challenges for the radiologist, particularly if imaging findings are not classic for gynecomastia or carcinoma. In this paper we review 10 unusual male breast cases, 5 benign and 5 malignant, including the radiologic findings, differential diagnosis, pathology and management.

Optical Coherence Tomography: A Novel Imaging Method for Post-lumpectomy Breast Margin Assessment-A Multi-reader Study.

RATIONALE AND OBJECTIVES: This study aimed to assess whether different breast cancer subspecialty physicians can be trained to distinguish non-suspicious from suspicious areas of post-lumpectomy specimen margin in patients with breast cancer using optical coherence tomography (OCT) images (a near-infrared based imaging technique) with final histology as the reference standard. MATERIALS AND METHODS: This institutional review board-exempt, Health Insurance Portability and Accountability Act-compliant study was performed on 63 surgically excised breast specimens from 35 female patients, creating a 90-case atlas containing both non-suspicious and suspicious areas for cancer. OCT images of the specimens were performed, providing 6.5-15 µm resolution with tissue visualization 1-2 mm subsurface. From the 90-case atlas, 40 cases were chosen for training and 40 were randomly selected for reader assessment. Three breast imaging radiologists, two pathologists, two breast surgeons, and one non-clinical reader were trained and assessed for ability to distinguish non-suspicious from suspicious findings blinded to clinical data and corresponding histology slides. Duration of training and assessment, sensitivity, specificity, positive predictive value, negative predictive value, and the area under the curve for each reader were calculated as well as averages by subspecialty. RESULTS: The average training time was 3.4 hours (standard deviation, 1.2). The average assessment time was 1.9 hours (standard deviation, 0.7). The overall average reader sensitivity, specificity, and accuracy for detecting suspicious findings with histologic confirmation of cancer at the surgical margin for all eight readers were 80%, 87%, and 87%, respectively. Radiologists demonstrated the highest average among the disciplines, 85%, 93%, and 94%, followed by pathologists, 79%, 90%, and 84%, and surgeons, 76%, 84%, and 82% respectively. CONCLUSIONS: With relatively short training (3.4 hours), readers from different medical specialties were able to distinguish suspicious from non-suspicious OCT imaging findings in ex vivo breast tissue as confirmed by histology. These results support the potential of OCT as a real-time intraoperative tool for post-lumpectomy specimen margin assessment.

Artifacts in Breast Magnetic Resonance Imaging.

As breast magnetic resonance imaging has evolved to become a routine part of clinical practice, so too has the need for radiologists to be aware of its potential pitfalls and limitations. Unique challenges arise in the identification and remedy of artifacts in breast magnetic resonance imaging, and it is important that radiologists and technicians work together to optimize protocols and monitor examinations such that these may be minimized or avoided entirely. This article presents patient-related and technical artifacts that may give rise to reduced image quality and ways to recognize and reduce them.