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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm; Chemotherapy Effect
• Intervention / Treatment: Device: Magnetic seed localization

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chi Mei Vivian Man, FCSHK, FRCSEd; Phone Number: 852-25898116; Email: vivian27@hku.hk
• Study Contact Backup: Name: Christine Chan, Miss; Phone Number: 852-2255 4773; Email: tcc0525@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • University of Hong Kong
    • Contact: Christine Chan; Phone Number: 852-22554765; Email: tcc0525@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm; Magnetic seed guided lumpectomy and targeted axillary dissection	Device: Magnetic seed localization; Magnetic seed guided localization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful localization of breast tumor and axillary lymph node	Successful surgical retrieval of magnetic seed marked breast tumor and axillary lymph node in intraoperative specimen mammogram (in percentage)	At the time of operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients that can avoid axillary lymph node dissection	Percentage of patients that can achieve nodal pathological complete response after neoadjuvant chemotherapy	up to 4 weeks
Percentage of successful magnetic seed guided lumpectomy	Percentage of involved or close margins in lumpectomy specimen which require re-excision	up to 4 weeks
Level of satisfaction from surgeons and radiologists	Level of satisfaction from surgeons and radiologists which will be determined by the satisfaction questionnaire	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 ipsilateral breast tumor recurrence rate and/or axillary recurrence rate	5-year post-operatively

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Endomagnetics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UW 20-064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No