Magnetic seeds could guide surgeons to breast tumors without radioactive tracers
NCT ID NCT05142787
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing a system called Magseed Pro and Sentimag Gen3 to help surgeons find breast tumors and suspicious lymph nodes during surgery. The study enrolls 224 adults with breast cancer who need these areas marked and removed. Doctors place a small magnetic marker into the tumor or lymph node, then use a handheld device to locate it in the operating room. The main goal is to see how often the marker and the target tissue are successfully removed together.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Magseed Pro marker and Sentimag Gen3 localization system
- What this could lead to
- If it works, this could give surgeons a reliable way to find breast tumors and lymph nodes during surgery without using radioactive tracers or wires.
- What could go wrong
- The study is non-randomized and open-label, so results may not apply to all patients or hospitals. The marker may not always be retrieved with the target tissue, and the study does not compare the system directly against other localization methods.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 224 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study * Participant is aged 18 years or older at the time of consent. * Patients requiring breast lesion/axillary node marking and excision Exclusion Criteria:• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. A pregnancy test is required for all women of childbearing potential within 7 days before enrolment. * Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results * Known hypersensitivity to Nitinol * Subject has current active infection at the implantation site in the breast (per investigator discretion)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbH
RECRUITINGFrankfurt, Germany
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Guy's Hospital
RECRUITINGLondon, United Kingdom
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Marienhospital Bottrop GmbH
RECRUITINGBottrop, Germany
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Royal Marsden Hospital
RECRUITINGLondon, United Kingdom
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Technical University Munich
NOT_YET_RECRUITINGMunich, Germany
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University Hospital South Manchester
RECRUITINGManchester, United Kingdom
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