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AzTrials

Breast CancerNCT05142787

Magseed Pro(R)/ Sentimag(R) Gen3

A study testing Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics in people with Breast Cancer, run by Endomagnetics Ltd. at 6 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to provide prospective evidence that the Magseed Pro® marker /Sentimag® Gen3 system is safe and effective for marking A. suspicious/biopsy-proven positive axillary lymph nodes; and B. soft tissue lesions including cancer and pre-cancerous change in the breast Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
6 sitesin 2 countries
Study dates
2 Mar 2023to 30 Jun 2028
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

  • 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)

Who cannot join

None listed.

Trial locations and contacts

6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Matt Womack, Dr contact

+447851247439

mwomack@endomag.com

Tanja Odeneg, Dr contact

+441223652604

todeneg@endomag.com

6 sites in 2 countries

Germany3 sites, 3 recruiting
  • Marienhospital Bottrop GmbH

    Bottrop

    Hans Christian Kolberg

    Recruiting
  • AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbH

    Frankfurt

    Marc Thill

    Recruiting
  • Technical University Munich

    Munich

    Stefan Paepke

    Not yet recruiting

Other trials in Germany

United Kingdom3 sites, 3 recruiting
  • Guy's Hospital

    London

    Ashutosh Kothari

    Recruiting
  • Royal Marsden Hospital

    London

    Peter Barry

    Recruiting
  • University Hospital South Manchester

    Manchester

    James Harvey

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Prospective, Multi Center, International, Open Label Study of the Use of Magseed Pro(R) Markers and Sentimag(R) Gen3 to Localize Breast Lesions and Suspicious/Biopsy-proven Positive Lymph Nodes in Breast Cancer Patients

The purpose of this study is to provide prospective evidence that the Magseed Pro® marker /Sentimag® Gen3 system is safe and effective for marking A. suspicious/biopsy-proven positive axillary lymph nodes; and B. soft tissue lesions including cancer and pre-cancerous change in the breast

Read the detailed description

The purpose of this study is to provide prospective evidence that the Magseed Pro® marker /Sentimag® Gen3 system is safe and effective for marking A. suspicious/biopsy-proven positive axillary lymph nodes; and B. soft tissue lesions including cancer and pre-cancerous change in the breast The devices used in this clinical trial are the Magseed Pro® marker and Sentimag® Gen3 system by Endomagnetics Limited.

The Endomag Magseed Pro® Marker System is intended to be placed within the target soft tissue prior to planned surgical removal. The marker, when used in conjunction with the Sentimag® Gen 3 System, can be used as a guide for the surgeon to follow in the excision of tissue. The Sentimag® Gen3 Magnetic Localisation System when used with the Magseed family of markers is indicated to assist in localising soft tissue lesions.

The study design is a multicentre international prospective, open label, study of Magseed Pro® marker and Sentimag® Gen3 system in patients with breast and/or lymph node pathology with:

  1. axillary lymph nodes requiring localisation prior to surgical excision (suspicious and/or biopsy proven lymph node or other pathology indicating removal) and/or B. breast lesions requiring localisation

Patients will have the Magseed Pro® marker placed to mark A. surgical excision of suspicious/biopsy-proven axillary lymph node as part of a targeted lymph node biopsy procedure AND/OR B. breast lesions in patients undergoing surgical excision of the targeted breast lesion The Magseed Pro® marker will be localised using the Sentimag® Gen3 system and therafter surgically removed with the target tissue.

This study will enrol 224 patients; 112 with Magseed Pro® marker placed to mark breast lesions and 112 with Magseed Pro® marker placed to mark nodes.

The expected duration of enrolment is approximately 9 months across all sites with each individual subject's participation lasting approximately 1-38 weeks after enrolment.

Conditions
Breast Cancer
Being tested
Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics
Keywords
Magseed Pro, Sentimag Gen3
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 Pro(R) and Sentimag(R) Gen3 by EndomagneticsDevice

    placement of Magseed Pro \& localisation with Sentimag Gen3 in axillary lymph nodes and/or breast lesions

Study groups in NCT05142787
Study groupRoleWhat they receive
axillary lymph nodes requiring localisation prior to surgical excisionOtherThe Magseed Pro® marker is intended to be placed percutaneously in suspicious/biopsy proven positive axillary lymph nodes under imaging guidance to mark tissue intended for selective surgical removal. The Magseed Pro® marker is localised using the Sentimag® Gen3 system handheld probes and surgically removed within/from the target tissue.
Receives: Device: Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics
breast lesions requiring localisationOtherThe Magseed Pro® marker is intended to be placed percutaneously in breast lesions under imaging guidance to mark tissue intended for selective surgical removal. The Magseed Pro® marker is localised using the Sentimag® Gen3 system handheld probes and surgically removed within/from the target tissue.
Receives: Device: Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoints are the retrieval rates of the Magseed Pro® marker with the target lesion within the initial excised specimen for A.) axillary lymph nodes B.) breast lesions A.) axillary lymph nodes. B.) breast lesions

    This is defined as the number of patients with successful Magseed Pro® marker placement as demonstrated on imaging, in whom the Magseed Pro® marker and the associated lymph node and/ or lesion is retrieved, divided by the total number of subjects.

    Measured: time of surgery

Secondary outcomes (27)
  1. Tissue response (unexpected and expected)

    EXPECTED Early (up to 2 days) - acute inflammation in the form of neutrophils with lymphocytes and some associated haemorrhage.

    Late (>2 days) - active chronic inflammation in the form of neutrophils, lymphocytes, macrophages together with a fibroblastic response. Likely a foreign body reaction with increased numbers of histiocytes and some multinucleated giant cells. Possible granuloma formation (foreign body type). Scattered eosinophils. Later scarring (after 1-2 weeks) with fibrosis. Possible fat necrosis.

    UNEXPECTED Early and Late -

    • Very florid fibroblastic response with granulation tissue formation that mimics malignancy (nodular fasciitis-like), which may need immunohistochemical tests to differentiate between reactive chan

    Measured: time of surgery

  2. Presence of unexpected histological tissue response for short- and long-term use of Magseed Pro marker

    UNEXPECTED HISTOLOGICAL RESPONSE Early and Late -

    • Very florid fibroblastic response with granulation tissue formation that mimics malignancy (nodular fasciitis-like), which may need immunohistochemical tests to differentiate between reactive chan

    Measured: time of surgery

  3. Rate of device-related AE's and SAE's

    Rate of device-related AE's and SAE's

    Measured: through study completion, an average of 38 weeks

  4. Retrieval rate for all lesions

    Retrieval rate for all lesions (including target, non-target lesions and multiple lesions per patient) out of the total number of lesions with a Magseed Pro® marker placement. Non-target lesions include additional marked lesions which weren't defined as the target for the primary endpoint and any marked lesions from patients undergoing long term node retrieval.

    Measured: time of surgery

  5. Retrieval rate for all nodes

    Retrieval rate for all nodes (including multiple nodes per patient where applicable) out of the total number of nodes with a Magseed Pro® marker placement.

    Measured: time of surgery

  6. Per lesion retrieval rate for target excised specimens

    Per lesion retrieval rate for target excised specimens

    Measured: time of surgery

  7. Per lesion retrieval rate for all excised specimens

    Per lesion retrieval rate for all excised specimens

    Measured: time of surgery

  8. Per lesion retrieval rate for all lesion

    Per lesion retrieval rate for all lesion

    Measured: time of surgery

  9. Per lesion retrieval rate for all nodes

    Per lesion retrieval rate for all nodes

    Measured: time of surgery

  10. Per patient retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy

    Per patient retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy

    Measured: time of surgery

  11. Per lesion retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy.

    Per lesion retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy.

    Measured: time of surgery

  12. Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement.

    Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement.

    Measured: time of surgery

  13. Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement.

    Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement.

    Measured: time of surgery

  14. Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement

    Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement

    Measured: time of surgery

  15. Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement.

    Per lesion retrieval rate for Magseed Pro® marker where retrieval surgery is greater than 30 days after placement.

    Measured: time of surgery

  16. Per lesion retrieval rate for target excised specimens (i.e., lesions plus nodes) where Magtrace® Tracer is present in the target node or in the region of the target lesion.

    Per lesion retrieval rate for target excised specimens (i.e., lesions plus nodes) where Magtrace® Tracer is present in the target node or in the region of the target lesion.

    Measured: time of surgery

  17. Per lesion retrieval rate for all excised specimens (i.e., lesions plus nodes) where Magtrace® Tracer is present in the target node or in the region of the target lesion.

    Per lesion retrieval rate for all excised specimens (i.e., lesions plus nodes) where Magtrace® Tracer is present in the target node or in the region of the target lesion.

    Measured: time of surgery

  18. Per lesion retrieval rate for target lesions where Magtrace® Tracer is present in the region of the target lesion.

    Per lesion retrieval rate for target lesions where Magtrace® Tracer is present in the region of the target lesion.

    Measured: time of surgery

  19. Per lesion retrieval rate for all lesions where Magtrace® Tracer is present in the region of the lesion.

    Per lesion retrieval rate for all lesions where Magtrace® Tracer is present in the region of the lesion.

    Measured: time of surgery

  20. Per node retrieval rate for target nodes where Magtrace® Tracer is present in the target node.

    Per node retrieval rate for target nodes where Magtrace® Tracer is present in the target node.

    Measured: time of surgery

  21. Per node retrieval rate for all nodes where Magtrace® Tracer is present in the node.

    er node retrieval rate for all nodes where Magtrace® Tracer is present in the node.

    Measured: time of surgery

  22. Interventionist rated ease of Magseed Pro® marker placement by the interventionist

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

    Measured: seed placement

  23. Rate of deployment failure

    A Magseed Pro is not deployed from the needle, or is accidentally deployed prior to use in the patient

    • Success rate of seed placement:
    • Accurate: Within the breast lesion or clipped lymph node. For lesions less than 5 mm in size the marker may not necessarily be within the excised specimen but should be within 10mm1 of the lesion.
    • Inadequate: Not in the targeted lesion or clipped lymph node determined by placement imaging requiring additional marker placement

    Measured: seed placement

  24. Surgeon rated ease of intra-operative localisation

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

    Measured: time of surgery

  25. Magtrace® Tracer counts for excised lymph nodes during SLNB procedures

    Magtrace® Tracer counts for excised lymph nodes during SLNB procedures

    Measured: time of surgery

  26. Re-excision rate (i.e., second procedure required). With reason for second procedure.

    Re-excision rate (i.e., second procedure required). With reason for second procedure.

    Measured: time of surgery

  27. Success rate of maintained marker position at the time of removal as determined by specimen X-ray and or Sentimag Gen3 system.

    • Accurate: Magseed Pro® marker within the target lesion or marked lymph node.
    • Inadequate: Magseed Pro® marker not within the target lesion or marked lymph node

    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.

  1. First posted3 Dec 2021
  2. Study start2 Mar 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05142787
Sponsor's protocol ID
EU001
Status last verified
Sep 2026
First submitted
8 Nov 2021
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics in people with Breast Cancer, run by Endomagnetics Ltd. at 6 sites in 2 countries.

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 0 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 16 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 6 sites in Germany, United Kingdom. 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, Dr (+447851247439, mwomack@endomag.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoints are the retrieval rates of the Magseed Pro® marker with the target lesion within the initial excised specimen for A.) axillary lymph nodes B.) breast lesions A.) axillary lymph nodes. B.) breast lesions (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 16 Sep 2026.

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