ACR PRACTICE PARAMETER FOR THE PERFORMANCE OF PREOPERATIVE IMAGE-GUIDED LOCALIZATION IN THE BREAST

PREAMBLE

I. INTRODUCTION

II. INDICATIONS

III. QUALIFICATIONS AND RESPONSIBILITIES OF PERSONNEL

IV. WRITTEN REQUEST FOR THE EXAMINATION

V. SPECIFICATIONS OF THE PROCEDURE

A. Localization Techniques

1. Wire Localizations

V. SPECIFICATIONS OF THE PROCEDURE

A. Localization Techniques

2. NWL Devices

V. SPECIFICATIONS OF THE PROCEDURE

B. Specimen Imaging

V. SPECIFICATIONS OF THE PROCEDURE

C. Targeted axillary dissection

VI. DOCUMENTATION

VII. QUALITY CONTROL, AND IMPROVEMENT, SAFETY, INFECTION CONTROL, AND PATIENT EDUCATION

VIII. EQUIPMENT

ACKNOWLEDGEMENTS

Writing Committee – members represent their societies in the initial and final revision of this practice parameter

ACR
Aminololama-Shakeri, Shadi MD, Chair
Kraay, Michelle MD
Lenderink-Carpenter, Amanda M MD
Loomans, Rachel U MD
Loving, Vilert A MD
Spear, Georgia G MD
Strigel, Roberta M MD

Committee on Practice Parameters – Breast Imaging

(ACR Committee responsible for sponsoring the draft through the process)

Strigel, Roberta M MD, Chair	Aminololama-Shakeri, Shadi MD	Kohr, Jennifer MD	Kraay, Michelle MD
Lee, Cindy MD	Lenderink-Carpenter, Amanda M MD	Loomans, Rachel U MD	Lowry, Kathryn P MD
Miles, Randy MD	Rosen, Eric MD	Seiler, Stephen J MD	Slanetz, Priscilla J MD, MPH
Spear, Georgia G MD	Sung, Janice S MD

Committee on Practice Parameters and Technical Standards

(ACR Committee responsible for sponsoring the draft through the process)

Caplin, Drew M MD, Chair

Destounis, Stamatia V MD, Chair, Commission on Breast Imaging

Larson, David B MBA, MD, Chair, Commission on Quality and Safety

Comments Reconciliation Committee

Elahi, Fatima DO, MHA - CSC, Co-Chair	Rodgers, Daniel MD - CSC, Chair	Aminololama-Shakeri, Shadi MD	Caplin, Drew M MD
Crummy, Timothy MD, MHA - CSC	Destounis, Stamatia V MD	Kraay, Michelle MD	Larson, David B MBA, MD
Lee, Cindy MD	Lenderink-Carpenter, Amanda M MD	Loomans, Rachel U MD	Loving, Vilert A MD
Schoppe, Kurt MD - CSC	Spear, Georgia G MD	Strigel, Roberta M MD

REFERENCES

1. [28968154] Jeffries DO, Dossett LA, Jorns JM. Localization for Breast Surgery: The Next Generation. Arch Pathol Lab Med. 2017 Oct;141(10):1324-1329.
2. [34612680] Guirguis MS, Adrada BE, Scoggins ME, et al. The Challenging Image-Guided Preoperative Breast Localization: A Modality-Based Approach. AJR Am J Roentgenol. 2022 Mar;218(3):423-434.
3. [38424951] Davis KM, Raybon CP, Monga N, et al. Image-guided Localization Techniques for Nonpalpable Breast Lesions: An Opportunity for Multidisciplinary Patient-centered Care. J Breast Imaging. 2021 Sep 16;3(5):542-555.
4. [-3197852] Food and Drug Administration. Mammography quality standards; final rule. Available at: https://www.federalregister.gov/documents/2023/03/10/2023-04550/mammography-quality-standards-act.
5. [-3098658] American College of Radiology. ACR Practice Parameter for the Performance of Stereotactic/Tomosynthesis-Guided Breast Interventional Procedures. Available at: https://gravitas.acr.org/PPTS/GetDocumentView?docId=65+&releaseId=2
6. [-3098656] American College of Radiology. ACR Practice Parameter for the Performance of Ultrasound-Guided Percutaneous Breast Interventional Procedures. Available at: https://gravitas.acr.org/PPTS/GetDocumentView?docId=125+&releaseId=2
7. [-3098655] American College of Radiology. ACR Practice Parameter for the Performance of a Diagnostic Breast Ultrasound Examination. Available at: https://gravitas.acr.org/PPTS/GetDocumentView?docId=124+&releaseId=2
8. [-3196807] American College of Radiology. ACR Practice Parameter for the Performance of Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast. Available at: https://gravitas.acr.org/PPTS/GetDocumentView?docId=6+&releaseId=2
9. [-3197625] American College of Radiology. ACR Practice Parameter for the Performance of Magnetic Resonance Imaging-Guided Breast Interventional Procedures. Available at https://gravitas.acr.org/PPTS/GetDocumentView?docId=123+&releaseId=2
10. [-3196801] American College of Radiology. ACR Practice Parameter for the Performance of Screening and Diagnostic Mammography. Available at: https://gravitas.acr.org/PPTS/GetDocumentView?docId=8+&releaseId=2
11. [18722938] Kirstein LJ, Rafferty E, Specht MC, et al. Outcomes of multiple wire localization for larger breast cancers: when can mastectomy be avoided?. J Am Coll Surg. 2008 Sep;207(3):342-6.
12. [11517048] Liberman L, Kaplan J, Van Zee KJ, et al. Bracketing wires for preoperative breast needle localization. AJR Am J Roentgenol. 2001 Sep;177(3):565-72.
13. [32667855] Choudhery S, Anderson T. Tomosynthesis-guided breast and axillary localizations: tips and tricks. Br J Radiol. 2020 Oct 01;93(1114):20200495.
14. [25794081] Sharek D, Zuley ML, Zhang JY, Soran A, Ahrendt GM, Ganott MA. Radioactive seed localization versus wire localization for lumpectomies: a comparison of outcomes. AJR Am J Roentgenol. 2015 Apr;204(4):872-7.
15. [27275652] Gao Y, Bagadiya NR, Jardon ML, et al. Outcomes of Preoperative MRI-Guided Needle Localization of Nonpalpable Mammographically Occult Breast Lesions. AJR Am J Roentgenol. 2016 Sep;207(3):676-84.
16. [36831516] Banys-Paluchowski M, Kühn T, Masannat Y, et al. Localization Techniques for Non-Palpable Breast Lesions: Current Status, Knowledge Gaps, and Rationale for the MELODY Study (EUBREAST-4/iBRA-NET, NCT 05559411). Cancers (Basel). 2023 Feb 12;15(4):1173.
17. [29271240] Cheang E, Ha R, Thornton CM, Mango VL. Innovations in image-guided preoperative breast lesion localization. [Review]. Br J Radiol. 91(1085):20170740, 2018 May.
18. [18248562] Hughes JH, Mason MC, Gray RJ, et al. A multi-site validation trial of radioactive seed localization as an alternative to wire localization. Breast J. 2008;14(2):153-7.
19. [19954769] Jakub JW, Gray RJ, Degnim AC, Boughey JC, Gardner M, Cox CE. Current status of radioactive seed for localization of non palpable breast lesions. [Review] [19 refs]. Am J Surg. 199(4):522-8, 2010 Apr.
20. [21947587] McGhan LJ, McKeever SC, Pockaj BA, et al. Radioactive seed localization for nonpalpable breast lesions: review of 1,000 consecutive procedures at a single institution. Ann Surg Oncol. 2011 Oct;18(11):3096-101.
21. [31448530] Srour MK, Kim S, Amersi F, Giuliano AE, Chung A. Comparison of wire localization, radioactive seed, and Savi scout® radar for management of surgical breast disease. Breast J. 2020 Mar;26(3):406-413.
22. [35089321] Dave RV, Barrett E, Morgan J, et al. Wire- and magnetic-seed-guided localization of impalpable breast lesions: iBRA-NET localisation study. Br J Surg. 2022 Feb 24;109(3):274-282.
23. [32363081] Lee C, Bhatt A, Felmlee JP, et al. How to Safely Perform Magnetic Resonance Imaging-guided Radioactive Seed Localizations in the Breast. J Clin Imaging Sci. 2020;10():19.
24. [21906208] Alderliesten T, Loo CE, Pengel KE, Rutgers EJ, Gilhuijs KG, Vrancken Peeters MJ. Radioactive seed localization of breast lesions: an adequate localization method without seed migration. Breast J. 2011;17(6):594-601.
25. [27007608] Dryden MJ, Dogan BE, Fox P, et al. Imaging Factors That Influence Surgical Margins After Preoperative 125I Radioactive Seed Localization of Breast Lesions: Comparison With Wire Localization. AJR Am J Roentgenol. 2016 May;206(5):1112-8.
26. [26274097] Goudreau SH, Joseph JP, Seiler SJ. Preoperative Radioactive Seed Localization for Nonpalpable Breast Lesions: Technique, Pitfalls, and Solutions. Radiographics. 2015;35(5):1319-34.
27. [28411682] Hayes MK. Update on Preoperative Breast Localization. Radiol Clin North Am. 2017 May;55(3):S0033-8389(16)30211-1.
28. [27469121] Cox CE, Russell S, Prowler V, et al. A Prospective, Single Arm, Multi-site, Clinical Evaluation of a Nonradioactive Surgical Guidance Technology for the Location of Nonpalpable Breast Lesions during Excision. Ann Surg Oncol. 23(10):3168-74, 2016 10.
29. [27304083] Mango V, Ha R, Gomberawalla A, Wynn R, Feldman S. Evaluation of the SAVI SCOUT Surgical Guidance System for Localization and Excision of Nonpalpable Breast Lesions: A Feasibility Study. AJR Am J Roentgenol. 2016 Oct;207(4):W69-W72.
30. [29446680] Price ER, Khoury AL, Esserman LJ, Joe BN, Alvarado MD. Initial Clinical Experience With an Inducible Magnetic Seed System for Preoperative Breast Lesion Localization. AJR Am J Roentgenol. 2018 Apr;210(4):913-917.
31. [29453521] Harvey JR, Lim Y, Murphy J, et al. Safety and feasibility of breast lesion localization using magnetic seeds (Magseed): a multi-centre, open-label cohort study. Breast Cancer Res Treat. 2018 Jun;169(3):531-536.
32. [30085842] Lamb LR, Bahl M, Specht MC, D'Alessandro HA, Lehman CD. Evaluation of a Nonradioactive Magnetic Marker Wireless Localization Program. AJR Am J Roentgenol. 2018 Oct;211(4):940-945.
33. [35298763] Liang DH, Black D, Yi M, et al. Correction to: Clinical Outcomes Using Magnetic Seeds as a Non-wire, Non-radioactive Alternative for Localization of Non-palpable Breast Lesions. Ann Surg Oncol. 2022 Mar 17;().
34. [37704563] Depretto C, Della Pepa G, De Berardinis C, et al. Magnetic Localization of Breast Lesions: A Large-Scale European Evaluation in a National Cancer Institute. Clinical Breast Cancer. 23(8):e491-e498, 2023 12.
35. [31560614] Kapoor MM, Patel MM, Scoggins ME. The Wire and Beyond: Recent Advances in Breast Imaging Preoperative Needle Localization. [Review]. Radiographics. 39(7):1886-1906, 2019 Nov-Dec.
36. [33084384] Lamb LR, Gilman L, Specht M, D'Alessandro HA, Miles RC, Lehman CD. Retrospective Review of Preoperative Radiofrequency Tag Localization of Breast Lesions in 848 Patients. AJR Am J Roentgenol. 217(3):605-612, 2021 09.
37. [35317766] den Dekker BM, Christenhusz A, van Dalen T, et al. A multicenter prospective cohort study to evaluate feasibility of radio-frequency identification surgical guidance for nonpalpable breast lesions: design and rationale of the RFID Localizer 1 Trial. BMC Cancer. 2022 Mar 22;22(1):305.
38. [33025481] Goyal A, Puri S, Marshall A, et al. A multicentre prospective feasibility study of carbon dye tattooing of biopsied axillary node and surgical localisation in breast cancer patients. Breast Cancer Res Treat. 2021 Jan;185(2):433-440.
39. [37749932] Hefelfinger L, Doherty A, Wahab R, Rosen L, Shaughnessy EA, Lewis JD. Evaluation of the SmartClip™ Nonradioactive Seed, a Novel Wireless Localization Method for the Breast: Initial Clinical Experience and Surgical Outcome. Am Surg. 2024 Apr;90(4):592-599.
40. [8273685] Graham RA, Homer MJ, Sigler CJ, et al. The efficacy of specimen radiography in evaluating the surgical margins of impalpable breast carcinoma. AJR Am J Roentgenol. 1994 Jan;162(1):33-6.
41. [7998574] Lee CH, Carter D. Detecting residual tumor after excisional biopsy of impalpable breast carcinoma: efficacy of comparing preoperative mammograms with radiographs of the biopsy specimen. AJR Am J Roentgenol. 1995 Jan;164(1):81-6.
42. [16554572] Mesurolle B, El-Khoury M, Hori D, et al. Sonography of postexcision specimens of nonpalpable breast lesions: value, limitations, and description of a method. AJR Am J Roentgenol. 2006 Apr;186(4):1014-24.
43. [31300313] Mario J, Venkataraman S, Fein-Zachary V, Knox M, Brook A, Slanetz P. Lumpectomy Specimen Radiography: Does Orientation or 3-Dimensional Tomosynthesis Improve Margin Assessment?. Can Assoc Radiol J. 70(3):282-291, 2019 Aug.
44. [32740738] Partain N, Calvo C, Mokdad A, et al. Differences in Re-excision Rates for Breast-Conserving Surgery Using Intraoperative 2D Versus 3D Tomosynthesis Specimen Radiograph. Ann Surg Oncol. 2020 Nov;27(12):4767-4776.
45. [3496752] Rebner M, Pennes DR, Baker DE, Adler DD, Boyd P. Two-view specimen radiography in surgical biopsy of nonpalpable breast masses. AJR Am J Roentgenol. 1987 Aug;149(2):283-5.
46. [38064928] Palimaru Manhoobi I, Tramm T, Redsted S, Bodilsen A, Foldager L, Christiansen P. Digital breast tomosynthesis versus X-ray of the breast specimen for intraoperative margin assessment: A randomized trial. Breast. 73:103616, 2024 Feb.
47. [17138112] Goldfeder S, Davis D, Cullinan J. Breast specimen radiography: can it predict margin status of excised breast carcinoma?. Acad Radiol. 2006 Dec;13(12):1453-9.
48. [15474443] McCormick JT, Keleher AJ, Tikhomirov VB, Budway RJ, Caushaj PF. Analysis of the use of specimen mammography in breast conservation therapy. Am J Surg. 2004 Oct;188(4):433-6.
49. [25517573] Caudle AS, Yang WT, Mittendorf EA, et al. Selective surgical localization of axillary lymph nodes containing metastases in patients with breast cancer: a prospective feasibility trial. JAMA Surg. 150(2):137-43, 2015 Feb.
50. [27726422] Shin K, Caudle AS, Kuerer HM, et al. Radiologic Mapping for Targeted Axillary Dissection: Needle Biopsy to Excision. AJR Am J Roentgenol. 207(6):1372-1379, 2016 Dec.
51. [28766234] Nguyen TT, Hieken TJ, Glazebrook KN, Boughey JC. Localizing the Clipped Node in Patients with Node-Positive Breast Cancer Treated with Neoadjuvant Chemotherapy: Early Learning Experience and Challenges. Ann Surg Oncol. 24(10):3011-3016, 2017 Oct.
52. [30673338] Choudhery S, Simmons C, Harper L, Lee CU. Tomosynthesis-Guided Needle Localization of Breast and Axillary Lesions: Our Initial Experience. AJR Am J Roentgenol 2019;212:943-46.
53. [30143401] Woods RW, Camp MS, Durr NJ, Harvey SC. A Review of Options for Localization of Axillary Lymph Nodes in the Treatment of Invasive Breast Cancer. Acad Radiol. 2019 Jun;26(6):S1076-6332(18)30369-6.
54. [37046791] Di Paola V, Mazzotta G, Conti M, et al. Image-Guided Localization Techniques for Metastatic Axillary Lymph Nodes in Breast Cancer; What Radiologists Should Know. Cancers (Basel). 2023 Apr 03;15(7):2130.
55. [-3197621] American College of Radiology. ACR Practice Parameter for Communication of Diagnostic Imaging Findings. Available at https://gravitas.acr.org/PPTS/GetDocumentView?docId=74+&releaseId=2