Clinical trial · Observational
Magseed and Magtrace Localization for Breast Cancer
Targeted Axillary Dissection, Sentinel Biopsy, and Tumor Lesion Localization in Breast Cancer Patients Using the New Magnetic "Sentimag" Detection System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy.
Conditions
Conditions (2)
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Carcinoma Metastatic in Lymph Node | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary lymph node metastasis - needle biopsy | Procedure | — | UNRESOLVED |
| Magseed | Procedure | — | UNRESOLVED |
| Magtrace | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Non-palpable breast cancer lesion
- description
- Patients with the non-palpable histologically confirmed breast cancer lesion that will undergo breast-conserving surgery and sentinel lymph node detection - the tumor lesion will be labeled with Magseed.
- interventionNames
- Procedure: Magseed
- label
- Palpable breast cancer lesion
- description
- Patients with the palpable histologically confirmed breast cancer lesion that will undergo breast-conserving surgery and sentinel lymph node detection - The Magtrace will be injected preoperatively into the tumor and detected by Sentimag.
- interventionNames
- Procedure: Magtrace
- label
- Axillary lymph node metastasis
- description
- Patients with the histologically confirmed breast cancer lesion with Axillary lymph node metastasis with pathologic confirmation by needle biopsy - the positive axillary lymph node lesion will be labeled with Magseed before the neoadjuvant systemic therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed cT0-4 breast cancer * Without/ With axillary lymph node metastasis with pathologic confirmation by needle biopsy * With/ without received neoadjuvant chemotherapy prior to surgical resection Exclusion Criteria: * Distant metastases * The subject is known to be pregnant * Pacemaker of another implantable device in the chest wall * Allergy to dextran or other iron-containing particles
References
Publications (3)
- BACKGROUNDRubio IT, Diaz-Botero S, Esgueva A, Rodriguez R, Cortadellas T, Cordoba O, Espinosa-Bravo M. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015 Jan;41(1):46-51. doi: 10.1016/j.ejso.2014.11.006. Epub 2014 Nov 15. PMID 25466980
- BACKGROUNDGreenwood HI, Wong JM, Mukhtar RA, Alvarado MD, Price ER. Feasibility of Magnetic Seeds for Preoperative Localization of Axillary Lymph Nodes in Breast Cancer Treatment. AJR Am J Roentgenol. 2019 Oct;213(4):953-957. doi: 10.2214/AJR.19.21378. Epub 2019 Jun 5. PMID 31166765
- BACKGROUNDZacharioudakis K, Down S, Bholah Z, Lee S, Khan T, Maxwell AJ, Howe M, Harvey J. Is the future magnetic? Magseed localisation for non palpable breast cancer. A multi-centre non randomised control study. Eur J Surg Oncol. 2019 Nov;45(11):2016-2021. doi: 10.1016/j.ejso.2019.06.035. Epub 2019 Jun 26. PMID 31288944