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

NCT ID: NCT05427071

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2028-12-31

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.

Conditions

Breast Neoplasm; Chemotherapy Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study arm

Magnetic seed guided lumpectomy and targeted axillary dissection

Group Type: EXPERIMENTAL

Magnetic seed localization

Intervention Type: DEVICE

Magnetic seed guided localization

Interventions

Magnetic seed localization

Magnetic seed guided localization

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endomagnetics Ltd.

INDUSTRY

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor Ava Kwong

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Chi Mei Vivian Man, FCSHK, FRCSEd

Role: CONTACT

vivian27@hku.hk

852-25898116

Christine Chan, Miss

Role: CONTACT

tcc0525@hku.hk

852-2255 4773

Facility Contacts

Christine Chan

Role: primary

tcc0525@hku.hk

852-22554765

Candy

Role: backup

kakai@hku.hk

852-22554773

Other Identifiers

UW 20-064

Identifier Type: -

Identifier Source: org_study_id