NCT03796559 · Endomagnetics Ltd.
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
(MAGELLAN)
What this study is about
The purpose of this study is to provide forward-looking 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 19, 2024 · Source of record for eligibility and locations