Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
NCT ID: NCT03796559
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
65 participants
INTERVENTIONAL
2019-06-13
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Magseed marker
Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC.
Magseed Marker
Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.
Interventions
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Magseed Marker
Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Endomagnetics Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Abigail Caudle, MD, MS
Role: PRINCIPAL_INVESTIGATOR
MD Anderson Cancer Center, Houston, TX
Locations
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Baylor Medicine
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Kelly Hunt, MD, F.A.C.S.
Role: backup
Other Identifiers
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US-003
Identifier Type: -
Identifier Source: org_study_id
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