Axillary Lymph Nodes, Breast Cancer
Conditions
Keywords
Neo-adjuvant chemotherapy
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 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
DEVICEMagseed Marker
Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.
Sponsors
Endomagnetics Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retrieval rate of clipped node and Magseed in the excised specimen | Time of surgery | The retrieval rate of the clipped node and Magseed in the excised specimen. This is defined as the number of subjects in whom the clipped node and Magseed are retrieved in a single excised specimen divided by the total number of subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of device and serious device-related events | Up to 42 days post-surgery | Rates of device-related adverse events and serious device-related adverse events |
| Radiologic rated ease of Magseed placement | Time of Magseed marker placement | 5 point Likert scale, very easy = 5, very difficult = 1 |
| Radiologic placement accuracy | Between completion of NAC time of surgery | Success rate of seed placement (placement accuracy) |
| Radiologic seed position | After completion of NAC | Success rate of maintained seed position at the completion of NAC |
| Surgical nodes localized | Time of surgery | Number of nodes retrieved within the surgical specimen containing the Magseed |
| Ease of surgical localization | Time of surgery | 5 point Likert scalevery easy = 5, very difficult = 1 |
Countries
United States
Contacts
CONTACTMatt Womack, PhD
PRINCIPAL_INVESTIGATORAbigail Caudle, MD, MS
MD Anderson Cancer Center, Houston, TX
Outcome results
None listed