NCT05427071

Magnetic Marker Localization for Occult Breast Cancer and Target Axillary Dissection in Node-positive Breast Cancer Post-neoadjuvant Chemotherapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 operation. However, breast tumor and involved axillary lymph node should be marked before the commencement of chemotherapy. This could facilitate subsequent operative planning and intraoperative assessment of disease response. This study aims to evaluate the feasibility of magnetic marker localization for non-palpable breast cancer and targeted axillary dissection in patients with node-positive breast cancer following neoadjuvant therapy

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 commencement of neoadjuvant treatment. Chemotherapeutic regimes will be determined by oncologists in charge. During the period of neoadjuvant treatment, patients will be followed up by oncologists and surgeons with clinical assessment of tumor response according to our usual practice. After completion of neoadjuvant chemotherapy, recruited patients will receive mammography and ultrasonography assessment before surgery. Breast conservative surgery with targeted axillary dissection will be offered when feasible. In patients not suitable for breast conservative surgery, mastectomy and targeted axillary dissection with or without immediate breast reconstruction will be offered. Patient will receive localization of previously marked axillary lymph node and breast tumor and sentinel lymph node biopsy by magnetic means completely, i.e. by the use if magnetic seeds and superparamagnetic iron oxide injection. Radioisotope with Tc-99 is injected prior to operation as backup plan for sentinel lymph node biopsy. The clipped lymph node and sentinel lymph nodes are sent for frozen section analysis. If any of the lymph nodes is positive for malignancy, axillary dissection will be performed. Similarly, the breast tumor will be resected with guidance of magnetometer and specimen mammogram will confirm the presence of tumor and magnetic seeds.

Conditions

• Breast Neoplasm
• Chemotherapy Effect

Interventions

Type	Name	Description
DEVICE	Magnetic seed localization	Magnetic seed guided localization

Timeline

• Start date: 2020-10-15
• Primary completion: 2023-12-31
• Completion: 2028-12-31
• First posted: 2022-06-22
• Last updated: 2022-06-22

Locations

1 site across 1 country: Hong Kong