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.
- Breast Cancer With Low to Intermediate HER2 Expression
- Breast Cancer (Triple Negative Breast Cancer (TNBC))
- Breast Cancer (Triple Negative Type)
- Breast Cancer - Infiltrating Ductal Carcinoma
- Breast Cancer - Ductal Carcinoma in Situ (DCIS)
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- King Faisal Specialist Hospital & Research Center
- Enrolment target
- 35
- Started
- 24 July 2026
- Main results due
- 31 August 2028
- Study sites
- 1
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
King Faisal Specialist Hospital and Research Center
Madinah, Saudi Arabia
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07844473. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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