ClinicalTrials.gg
RecruitingNCT03796559MAGELLANUpdated Sep 18, 2026

Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

An interventional study of Magseed Marker in Breast Cancer and Axillary Lymph Nodes, sponsored by Endomagnetics Ltd.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Endomagnetics Ltd. (part of Hologic, Inc.) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2019; still recruiting 7 years 5 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 14 studies in Breast Neoplasms by Hologic, Inc. — 3 open to participants now, 4 under way, none of them phase 3. Breast Neoplasms · Hologic, Inc..

Started
2019
the only one that year
No phase
7 of 14
2 open now
Registered
10th of 14
by date

Among the 14 studies in Breast Neoplasms by Hologic, Inc., this one is the only one that started in 2019, is one of 7 with no phase, and was the 10th registered.

Breast Neoplasms

14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

3 of the 14 studies in Breast Neoplasms by Hologic, Inc. are open now, in 3 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Who these studies take

Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 14 studies in Breast Neoplasms by Hologic, Inc., or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Breast Cancer
  • Axillary Lymph Nodes

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Keywords

  • Neo-adjuvant chemotherapy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older at time of consent
  • confirmed cT0-4, N1 breast cancer
  • Axillary lymph node with pathologic confirmation by needle
  • Clip placed in the sampled axillary lymph node before initiation of chemotherapy
  • Planned for 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
  • performance status 0-2

Exclusion criteria

Exclusion Criteria:

  • Distant
  • 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    Magseed marker

    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.

    Device: Magseed Marker

Interventions

  • DeviceMagseed Marker

    Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Time of surgery

Secondary outcomes

  1. Rates of device and serious device-related events

    Rates of device-related adverse events and serious device-related adverse events

    Time frame: Up to 42 days post-surgery

  2. Radiologic rated ease of Magseed placement

    5 point Likert scale, very easy = 5, very difficult = 1

    Time frame: Time of Magseed marker placement

  3. Radiologic placement accuracy

    Success rate of seed placement (placement accuracy)

    Time frame: Between completion of NAC time of surgery

  4. Radiologic seed position

    Success rate of maintained seed position at the completion of NAC

    Time frame: After completion of NAC

  5. Surgical nodes localized

    Number of nodes retrieved within the surgical specimen containing the Magseed

    Time frame: Time of surgery

  6. Ease of surgical localization

    5 point Likert scalevery easy = 5, very difficult = 1

    Time frame: Time of surgery

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2019 (actual). Primary completion is estimated for Dec 2026, 90 months after the start.

Of 110 industry-sponsored interventional studies with no phase under Breast Neoplasms, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 59. This study's planned 90 months is above that.

Counting every sponsor, half of 2,773 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2018
First posted
Jan 8, 2019
StartActual
Jun 13, 2019
Primary completionEst.
Dec 2026
CompletionEst.
May 2027
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03796559
Lead sponsor
Endomagnetics Ltd.
Responsible party
Sponsor
First posted
Jan 8, 2019
Start date
Jun 13, 2019
Primary completion
Dec 2026 (estimated)
Completion
May 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Matt Womack, PhD
Contact
mwomack@endomag.com
+447851247439
Abigail Caudle, MD, MS
principal investigator · MD Anderson Cancer Center, Houston, TX

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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