Clinical trial · Interventional
Use of Magtrace Bracketing for Excision of Lesion and Sentinel Lymph Node Localization in Breast Conserving Surgery for Breast Cancer
Use of Super Paramagnetic Iron Oxide (Magtrace) Bracketing for Excision of Lesion and Sentinel Lymph Node Localization in Breast Conserving Surgery for Breast Cancer - The MagBracket Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
Breast cancer is the commonest cancer affecting women worldwide. Early breast cancer is treated surgically with wide local excision of tumor with axillary staging operations like sentinel node biopsy. Surgical adjuncts used in identifying and localizing the area for excision include metallic wire, radioactive or magnetic seeds and radiofrequency reflectors. These are placed in the lesion under image guidance by the breast radiologists, either on the day of surgery (wires) or prior (seeds). Bracketing localization is performed in case of multiple lesions or wide spread calcifications to aid the surgeons in performing wide local excision of all involved areas. This means placing multiple devices around the area of excision for accurate triangulation, which increase the costs significantly. Localization agents like radionucleotide labelled albumin, super paramagnetic iron oxide (SPIO) and colored dyes like methylene blue, isosulphane blue and indocyanine green are injected in the breast for identification of sentinel lymph nodes in the axilla. More recent studies have demonstrated successful use of SPIO in localization of small impalpable breast cancer lesions. This also raises the prospect of using SPIO for the dual purpose of lesion localization / bracketing and sentinel node biopsy. This study was designed to test this principle in patients requiring bracketing. This is a prospective proof-of-concept pilot study to evaluate the feasibility of SPIO (Magtrace®) as a single-agent solution for bracketing the excision area and localizing the sentinel lymph node for breast-conserving surgery. Patients with breast cancer requiring bracketing and sentinel node biopsy will be identified through multidisciplinary breast tumor board and invited to take part in the study. All patients who consent to participate will receive an injection of Magtrace® for bracketing (0.5ml each at four points around the excision area) one day before surgery under ultrasound guidance. Primary outcome will be successful localization of the Magtrace® signal in breast for bracketing and in the sentinel node, using a magnetic probe on the day of surgery. Clinical outcomes, complications and cost analyses will be performed as secondary outcomes. We anticipate a sample size of 35 patients to be recruited for the study.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer - Ductal Carcinoma in Situ (DCIS) | Intraductal Carcinoma | CURATED_BROADER | 0.80 |
| Breast Cancer - Infiltrating Ductal Carcinoma | — | UNRESOLVED | — |
| Breast Cancer (Triple Negative Breast Cancer (TNBC)) | — | UNRESOLVED | — |
| Breast Cancer (Triple Negative Type) | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
| Breast Cancer With Low to Intermediate HER2 Expression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Super paramagnetic iron oxide bracketing injection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Magtrace Bracketing
- description
- Patients identified from breast multidisciplinary team meeting who require breast conserving surgery with bracketing required for the area of excision, with sentinel lymph node biopsy simultaneously will be recruited to the study (single intervention arm). Informed consent will be obtained for all patients who agree to take part in the study. Patients who agree to participate will receive Magtrace Injection in the breast one day before surgery. Magtrace will be injected at four points around the area to excised for bracketing.
- interventionNames
- Other: Super paramagnetic iron oxide bracketing injection
Primary outcomes (1)
- measure
- Success localization of bracketing Magtrace injection with Magnetic probe
- timeFrame
- Morning of surgery.
- description
- A hand held magnetic localization probe (Sentimag) will be used on the morning of surgery by the operating surgeon to localize the signal of Magtrace at four points bracketed around the area of the breast to be excised. For the bracketing localization to be considered successful, signal localization will be required to be present at all four points.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All patients with breast cancer undergoing breast conserving surgery requiring bracketing of the area of excision (as determined by the multidisciplinary tumor board) and a sentinel lymph node biopsy for axillary staging. Exclusion Criteria: 1. Patients having mastectomy. 2. Patients unfit for breast conserving surgery due to inability to have adjuvant radiotherapy. 3. Patients requiring axillary clearance without sentinel node biopsy. 4. Patient undergoing breast conserving surgery without need for sentinel node biopsy. 5. Patient with metastatic breast cancer requiring palliative surgery for local control. 6. Patients not consenting for research. 7. Patient with allergy to Magtrace.
References
Publications (7)
- BACKGROUNDDa Silva M, Porembka J, Mokdad AA, Seiler S, Huth J, Rivers A, Wooldridge R, Chu A, Brown E, Bao J, Farr D, Hansen M, Unzeitig-Barron A, Leitch M, Rao R. Bracketed radioactive seed localization vs bracketed wire-localization in breast surgery. Breast J. 2018 Mar;24(2):161-166. doi: 10.1111/tbj.12854. Epub 2017 Jul 14. PMID 28707718
- BACKGROUNDLyons W, Lamm R, Duffner ER, Shames J, Willis AI, Lazar M. Bracketed Localization in Breast-Conserving Surgery: Indications and Success Rates From a Single, High Volume, Academic Breast Cancer Center. Am Surg. 2023 Nov;89(11):4373-4378. doi: 10.1177/00031348221111516. Epub 2022 Jun 27. PMID 35758520
- BACKGROUNDDavis KM, Raybon CP, Monga N, Waheed U, Michaels A, Henry C, Spalluto LB. 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. doi: 10.1093/jbi/wbab061. PMID 38424951
- BACKGROUNDCheung BHH, Co M, Lui TTN, Kwong A. Evolution of localization methods for non-palpable breast lesions: a literature review from a translational medicine perspective. Transl Breast Cancer Res. 2024 Apr 15;5:12. doi: 10.21037/tbcr-23-49. eCollection 2024. PMID 38751684
- BACKGROUNDLiberman L, Kaplan J, Van Zee KJ, Morris EA, LaTrenta LR, Abramson AF, Dershaw DD. Bracketing wires for preoperative breast needle localization. AJR Am J Roentgenol. 2001 Sep;177(3):565-72. doi: 10.2214/ajr.177.3.1770565. PMID 11517048
- BACKGROUNDAhmed M, Anninga B, Goyal S, Young P, Pankhurst QA, Douek M; MagSNOLL Trialists Group. Magnetic sentinel node and occult lesion localization in breast cancer (MagSNOLL Trial). Br J Surg. 2015 May;102(6):646-52. doi: 10.1002/bjs.9800. PMID 25868072
- BACKGROUNDTorras I, Cebrecos I, Castillo H, Mension E. Evolution of breast conserving surgery-current implementation of oncoplastic techniques in breast conserving surgery: a literature review. Gland Surg. 2024 Mar 27;13(3):412-425. doi: 10.21037/gs-23-454. Epub 2024 Mar 14.