Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
Recruiting now · Not applicable
Conditions studied: Breast Cancer, Axillary Lymph Nodes
In brief
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 neo-adjuvant chemotherapy (NAC) is effective.
Key facts
- Study ID
- NCT03796559
- Run by
- Endomagnetics Ltd.
- People needed
- 65
- Starts
- 2019-06-13
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Baylor Medicine — Houston, Texas, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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