University of Hong Kong
Hong Kong
Location status: Recruiting
NCT Number: NCT05427071
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hong Kong
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Magnetic seed guided localization
Time frame: At the time of operation
Successful surgical retrieval of magnetic seed marked breast tumor and axillary lymph node in intraoperative specimen mammogram (in percentage)
Time frame: up to 4 weeks
Percentage of patients that can achieve nodal pathological complete response after neoadjuvant chemotherapy
Time frame: up to 4 weeks
Percentage of involved or close margins in lumpectomy specimen which require re-excision
Time frame: To be filled in by operating surgeons and radiologists at the time of operation or magnetic seeds placement
Level of satisfaction from surgeons and radiologists which will be determined by the satisfaction questionnaire
Time frame: 5-year post-operatively
5-year ipsilateral breast tumor recurrence rate and/or axillary recurrence rate
Contact information is provided by the study sponsor or research team.
Chi Mei Vivian Man, FCSHK, FRCSEd
CONTACT
Christine Chan, Miss
CONTACT
The University of Hong Kong
Other
Acronym: MaCTAD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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