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

NCT05427071 | Recruiting DMC

• 1 other identifier: UW 20-064
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Neoplasm; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Study arm

EXPERIMENTAL

Magnetic seed guided lumpectomy and targeted axillary dissection

Device: Magnetic seed localization

Interventions

Magnetic seed localization DEVICE

Magnetic seed guided localization

Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Endomagnetics Ltd.: collaborator

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Chi Mei Vivian Man, FCSHK, FRCSEd

CONTACT

852-25898116; vivian27@hku.hk

Christine Chan, Miss

CONTACT

852-2255 4773; tcc0525@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniel CK Yu Professor in Breast Cancer Research, Chief of Breast Surgery Division

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

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 22, 2022
• Study Start: October 15, 2020
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)