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

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

Sponsors

Lead Sponsor: The University of Hong Kong

Collaborator: Endomagnetics Ltd.

Source The University of Hong Kong
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 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.

Overall Status Recruiting
Start Date 2020-10-15
Completion Date 2028-12-31
Primary Completion Date 2023-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Successful localization of breast tumor and axillary lymph node At the time of operation
Secondary Outcome
Measure Time Frame
Percentage of patients that can avoid axillary lymph node dissection up to 4 weeks
Percentage of successful magnetic seed guided lumpectomy up to 4 weeks
Level of satisfaction from surgeons and radiologists To be filled in by operating surgeons and radiologists at the time of operation or magnetic seeds placement
5-year local regional recurrence rate 5-year post-operatively
Enrollment 30
Condition
Intervention

Intervention Type: Device

Intervention Name: Magnetic seed localization

Description: Magnetic seed guided localization

Arm Group Label: Study arm

Eligibility

Criteria:

Inclusion Criteria: - 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 Criteria: - 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Chi Mei Vivian Man, FCSHK, FRCSEd

Phone: 852-25898116

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: University of Hong Kong Christine Chan 852-22554765 [email protected]
Location Countries

Hong Kong

Verification Date

2022-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The University of Hong Kong

Investigator Full Name: Professor Ava Kwong

Investigator Title: Daniel CK Yu Professor in Breast Cancer Research, Chief of Breast Surgery Division

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Study arm

Type: Experimental

Description: Magnetic seed guided lumpectomy and targeted axillary dissection

Acronym MaCTAD
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: All patients received magnetic seeds guided localization of axillary lymph node and breast tumor and superparamagnetic iron oxide-guided sentinel lymph node biopsy

Primary Purpose: Treatment

Masking: None (Open Label)

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