Clinical trial · Interventional
Magseed Magnetic Marker in Locating Axillary Lymph Nodes in Patients With Breast Cancer Undergoing Surgery
A Prospective, Open Label Study of the Use of Magseed® and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-Proven Metastases in Breast Cancer Patients
NCT03038152CI-TRIAL-00050496completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase IV trial studies the side effects of the Magseed magnetic marker and how well it works in locating lymph nodes in the underarm area in patients with breast cancer undergoing surgery. Injecting a small metallic marker in or near the lymph node prior to surgery may help the surgeon locate the lymph nodes during surgery without using radiation.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma Metastatic in Lymph Node | — | UNRESOLVED | — |
| Stage IIA Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIB Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage II Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIIA Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary Lymph Node Dissection | Procedure | — | UNRESOLVED |
| Localization | Procedure | — | UNRESOLVED |
| Medical Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (Magseed marker)
- description
- Patients receive the Magseed marker via ultrasound guided injection into the previously clipped lymph node or within perinodal tissue =\< 3mm from the clipped node. Patients then undergo axillary lymph node localization and targeted dissection within 30 days.
- interventionNames
- Procedure: Axillary Lymph Node Dissection
- Procedure: Localization
- Device: Medical Device
Primary outcomes (2)
- measure
- Retrieval rate
- timeFrame
- Up to 15 months
- description
- Will be 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. For the analysis of retrieval rate, if the trial is not stopped early and all 50 patients are accrued, then point estimate along with 95% credible interval will be provided. Logistic regression model will be utilized to assess the association of patient demographic and clinical factors with the retrieval.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 completing chemotherapy * Received neoadjuvant chemotherapy prior to surgical resection * Scheduled for targeted axillary dissection (defined as selective localization and removal of the clipped node and sentinel lymph node dissection \[SLND\]) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Exclusion Criteria: * Distant metastases * Inflammatory breast cancer * Prior surgical axillary procedure including SLND or axillary node excision * Prior history of breast cancer in the ipsilateral breast * History of lymphoma * The subject is known to be pregnant. Premenopausal patients under the age of 50 must have a pregnancy test performed as standard of care before the MagSeed is placed * Previous radiation to the breast or axilla * Pacemaker of other implantable device in the chest wall
References
Publications (0)
Data not yet available
No reference posted for this study.