Status:
RECRUITING
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
Lead Sponsor:
Endomagnetics Ltd.
Conditions:
Breast Cancer
Axillary Lymph Nodes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following...
Detailed Description
This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the me...
Eligibility Criteria
Inclusion
- Age 18 years or older at time of consent
- Histologically confirmed cT0-4, N1 breast cancer
- Axillary lymph node metastasis with pathologic confirmation by needle biopsy
- Clip placed in the sampled axillary lymph node before initiation of chemotherapy
- Planned for neo-adjuvant chemotherapy prior to surgical resection
- Eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy
- ECOG performance status 0-2
Exclusion
- Distant metastases
- Inflammatory breast cancer
- Prior ipsilateral axillary surgical procedure including SLND or axillary node excision
- Prior history of breast cancer in the ipsilateral breast
- History of lymphoma
- Subject is pregnant
- Previous radiation to the breast or axilla
- Pacemaker or other implantable cardiac device in the ipsilateral chest wall
Key Trial Info
Start Date :
June 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03796559
Start Date
June 13 2019
End Date
May 1 2026
Last Update
September 19 2024
Active Locations (2)
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1
Baylor Medicine
Houston, Texas, United States, 77030
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030