Using Magseed to locate axillary lymph nodes in breast cancer patients
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
NA · Endomagnetics Ltd. · NCT03796559
This study is testing if a new marking system can help doctors find and remove lymph nodes in breast cancer patients after they have received chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Endomagnetics Ltd. (industry) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT03796559 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the Magseed and Sentimag systems in marking and surgically localizing axillary lymph nodes in breast cancer patients who have undergone neo-adjuvant chemotherapy. Participants will have a Magseed marker placed in their axillary lymph nodes before starting chemotherapy, and after treatment, the nodes will be localized and removed during surgery. The study is designed as a post-market, prospective, open-label, single-arm trial, focusing on patients with biopsy-proven axillary node metastases. The goal is to provide evidence for the effectiveness of this technique in improving surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-confirmed axillary lymph node metastasis from breast cancer who are scheduled for neo-adjuvant chemotherapy.
Not a fit: Patients with distant metastases, inflammatory breast cancer, or prior surgical procedures in the axilla may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the precision of surgical interventions for breast cancer patients, potentially leading to better outcomes.
How similar studies have performed: Other studies using similar localization techniques have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas and 1 other locations
- Baylor Medicine — Houston, Texas, United States (RECRUITING)
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Abigail Caudle, MD, MS — MD Anderson Cancer Center, Houston, TX
- Study coordinator: Matt Womack, PhD
- Email: mwomack@endomag.com
- Phone: +447851247439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Axillary Lymph Nodes, Neo-adjuvant chemotherapy