Clinical trial · Interventional
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
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
NCT03796559CI-TRIAL-00080858MAGELLANrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Axillary Lymph Nodes | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magseed Marker | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Magseed marker
- description
- 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.
- interventionNames
- Device: Magseed Marker
Primary outcomes (1)
- measure
- Retrieval rate of clipped node and Magseed in the excised specimen
- timeFrame
- Time of surgery
- description
- 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 outcomes (6)
- measure
- Rates of device and serious device-related events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.