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Use of Magtrace Bracketing for Excision of Lesion and Sentinel Lymph Node Localization in Breast Conserving Surgery for Breast Cancer

RecruitingNAAges 18 Years - anyAllKing Faisal Specialist Hospital & Research Center
NCT07844473 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Super paramagnetic iron oxide bracketing injection
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Where

1 site
King Faisal Specialist Hospital and Research Center
Madinah, Saudi Arabia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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