Breast CancerMAGELLANNCT03796559
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
A study testing Magseed Marker in people with Breast Cancer and Axillary Lymph Nodes, run by Endomagnetics Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Axillary Lymph Nodes
- What is being tested?
- Magseed Marker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jun 2019to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Baylor Medicine
Houston, Texas, 77030
Ivan Marin, ivan.marin@bcm.edu
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Veronika Noregil, VYNovegil@mdanderson.org
Kelly Hunt, MD, F.A.C.S.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Breast Cancer, Axillary Lymph Nodes
- Being tested
- Magseed Marker
- Keywords
- Neo-adjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magseed MarkerDevice
Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.
| Study group | Role | What they receive |
|---|---|---|
| Magseed marker | Experimental | 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. Receives: Device: Magseed Marker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrieval rate of clipped node and Magseed in the excised specimen
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.
Measured: Time of surgery
Secondary outcomes (6)
Rates of device and serious device-related events
Rates of device-related adverse events and serious device-related adverse events
Measured: Up to 42 days post-surgery
Radiologic rated ease of Magseed placement
5 point Likert scale, very easy = 5, very difficult = 1
Measured: Time of Magseed marker placement
Radiologic placement accuracy
Success rate of seed placement (placement accuracy)
Measured: Between completion of NAC time of surgery
Radiologic seed position
Success rate of maintained seed position at the completion of NAC
Measured: After completion of NAC
Surgical nodes localized
Number of nodes retrieved within the surgical specimen containing the Magseed
Measured: Time of surgery
Ease of surgical localization
5 point Likert scalevery easy = 5, very difficult = 1
Measured: Time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start13 Jun 2019
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endomagnetics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abigail Caudle, MD, MS, Principal investigator, MD Anderson Cancer Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796559
- Sponsor's protocol ID
- US-003
- Acronym
- MAGELLAN
- Status last verified
- Sep 2026
- First submitted
- 8 Nov 2018
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03796559
- Acronym / sponsor ID
- MAGELLAN / US-003
- Conditions
- Breast Cancer, Axillary Lymph Nodes
- Keywords
- Neo-adjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Endomagnetics Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magseed marker | Experimental | Device: Magseed MarkerMagseed 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magseed MarkerImplantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe. | Device | Magseed marker |
Primary outcome
Retrieval rate of clipped node and Magseed in the excised specimen
Time frame: 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.
6 secondary outcomes
Rates of device and serious device-related events
Time frame: Up to 42 days post-surgery
Radiologic rated ease of Magseed placement
Time frame: Time of Magseed marker placement
Radiologic placement accuracy
Time frame: Between completion of NAC time of surgery
Radiologic seed position
Time frame: After completion of NAC
Surgical nodes localized
Time frame: Time of surgery
Ease of surgical localization
Time frame: Time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abigail Caudle, MD, MS principal investigator
MD Anderson Cancer Center, Houston, TX
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magseed Marker in people with Breast Cancer and Axillary Lymph Nodes, run by Endomagnetics Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matt Womack, PhD (+447851247439, mwomack@endomag.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrieval rate of clipped node and Magseed in the excised specimen (time frame: Time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.