Recruiting NCT05142787

Magseed Pro(R)/ Sentimag(R) Gen3

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics.
Who it may be relevant to: Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Germany, United Kingdom
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Detailed description

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:

A. 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.

Interventions

Device Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics
placement of Magseed Pro \& localisation with Sentimag Gen3 in axillary lymph nodes and/or breast lesions

Primary outcome measures

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]

Secondary outcome measures (12)

Tissue response (unexpected and expected) [Time frame: time of surgery]
Presence of unexpected histological tissue response for short- and long-term use of Magseed Pro marker [Time frame: time of surgery]
Rate of device-related AE's and SAE's [Time frame: through study completion, an average of 38 weeks]
Retrieval rate for all lesions [Time frame: time of surgery]
Retrieval rate for all nodes [Time frame: time of surgery]
Per lesion retrieval rate for target excised specimens [Time frame: time of surgery]
Per lesion retrieval rate for all excised specimens [Time frame: time of surgery]
Per lesion retrieval rate for all lesion [Time frame: time of surgery]
Per lesion retrieval rate for all nodes [Time frame: time of surgery]
Per patient retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy [Time frame: time of surgery]
Per lesion retrieval rate for Magseed Pro® marker placed prior to neo-adjuvant therapy and retrieved post neo-adjuvant therapy. [Time frame: time of surgery]
Per patient retrieval rate for Magseed Pro® marker where retrieval surgery is within 30 days of placement. [Time frame: time of surgery]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Other

Study locations

Germany · 3 centers

Marienhospital Bottrop GmbH — Bottrop
AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbH — Frankfurt
Technical University Munich — Munich

United Kingdom · 3 centers

Guy's Hospital — London
Royal Marsden Hospital — London
University Hospital South Manchester — Manchester

Identifiers

NCT: NCT05142787 · EU001

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗