Status:
RECRUITING
Magnetic Marker Localization for Occult Breast Cancer and Target Axillary Dissection in Node-positive Breast Cancer Post-neoadjuvant Chemotherapy
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Endomagnetics Ltd.
Conditions:
Breast Neoplasm
Chemotherapy Effect
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The use of neoadjuvant chemotherapy in breast cancer is expanding in the recent decade. Patients with good response to neoadjuvant chemotherapy could benefit from de-escalation of breast and axilla op...
Detailed Description
Eligible patients will receive ultrasound guided placement of magnetic seeds (Magseed®) within the cortex of the sampled lymph node and epicenter of the breast tumor by radiologists before commencemen...
Eligibility Criteria
Inclusion
- All patients with cT1-3N1 invasive ductal carcinoma planned for neoadjuvant chemotherapy and/or target therapy
- mentally competent to give informed consent
- Agreed to proceed with curative operation after chemotherapy and tentatively keen for breast conservative surgery and targeted axillary dissection after neoadjuvant chemotherapy
- Radiologically 1-3 ipsilateral axillary lymph node metastases confirmed by cytology or biopsy
Exclusion
- Presence of distant metastasis, inflammatory breast cancers, multi-centric breast cancers
- History of previous ipsilateral axillary surgery or irradiation
- Hypersensitivity to dextran compounds or iron
- Iron overload disease
- Pregnant or lactating patients
- Patients with pacemaker or other implantable metallic devices in chest wall or prosthesis in shoulder
- Mentally incompetent patients
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05427071
Start Date
October 15 2020
End Date
December 31 2028
Last Update
June 22 2022
Active Locations (1)
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1
University of Hong Kong
Hong Kong, Hong Kong