Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magseed Marker.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Axillary Lymph Nodes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Open Label Study of the Use of Magseed® Markers and Sentimag® to Localize Axillary Lymph Nodes with Biopsy-proven Metastases in Breast Cancer Patients
Overview
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.
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 metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag system during surgery and removed with the targeted lymph node.
Interventions
- Device Magseed Marker
Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.
Primary outcome measures
- Retrieval rate of clipped node and Magseed in the excised specimen [Time frame: Time of surgery]
Secondary outcome measures (6)
- Rates of device and serious device-related events [Time frame: Up to 42 days post-surgery]
- Radiologic rated ease of Magseed placement [Time frame: Time of Magseed marker placement]
- Radiologic placement accuracy [Time frame: Between completion of NAC time of surgery]
- Radiologic seed position [Time frame: After completion of NAC]
- Surgical nodes localized [Time frame: Time of surgery]
- Ease of surgical localization [Time frame: Time of surgery]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Baylor Medicine — Houston
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT03796559 · US-003